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101. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

102. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Clinical Trials as Topic -- ethics
Clinical Trials as Topic -- methods
Ethics Committees, Research
Informed Consent
Randomized Controlled Trials as Topic -- ethics
Randomized Controlled Trials as Topic -- methods
Research Design
Research Subjects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

103. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

104. E18 genomic sampling and management of genomic data

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
Confidentiality
Genetic Testing
Genotyping Techniques
Information Management -- standards
Informed Consent
International Cooperation
Privacy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

105. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

106. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Drug Compounding -- standards
Liposomes -- chemistry
Liposomes -- pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Liposomes -- administration & dosage
Liposomes -- therapeutic use
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

107. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

108. Considerations for design, development, and analytical validation of next generation sequencing (NGS)--based in vitro diagnostics (IVDs) intended to aid in the diagnosis of suspected germline diseases: guidance for stakeholders and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018
Subject(s):: Genetic Testing
Germ-Line Mutation
Diagnostic Test Approval
Reagent Kits, Diagnostic -- standards
Sequence Analysis, DNA
Genomics
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

109. Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics: guidance for stakeholders and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018
Subject(s):: Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
Access to Information
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

110. Listing of ingredients in tobacco products: (revised)

Publication:: Silver Spring, MD : Center for Tobacco Products, Food and Drug Administration, April 2018
Subject(s):: Tobacco Products -- standards
Manufactured Materials -- standards
Tobacco
Tobacco Industry -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

111. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
Drug Contamination
Drug Labeling -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

112. Special protocol assessment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Protocols -- standards
Clinical Trials as Topic -- standards
Drug Approval
Drug Evaluation, Preclinical -- standards
Research Design
Carcinogenicity Tests -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

113. Clinical trial imaging endpoint process standards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Clinical Trials as Topic -- standards
Diagnostic Imaging -- standards
Endpoint Determination -- standards
Research Design -- standards
Observer Variation
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

114. Assessing user fees under the Prescription Drug User Fee Amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Fees and Charges
Investigational New Drug Application -- economics
Prescription Drugs -- economics
Biological Products -- economics
Orphan Drug Production -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

115. S3A guidance: note for guidance on toxicokinetics : the assessment of systemic exposure in toxicity studies : focus on microsampling : questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Blood Specimen Collection -- methods
Drug Evaluation, Preclinical -- methods
Pharmaceutical Preparations -- administration & dosage
Sample Size
Toxicity Tests -- methods
Toxicokinetics
Pharmacokinetics
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

116. Facility definition under Section 503B of the Federal Food, Drug, and Cosmetic Act

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Drug Compounding -- standards
Drug Industry -- standards
Contract Services
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

117. Establishing effectiveness for drugs intended to treat male hypogonadotropic hypogonadism attributed to nonstructural disorders

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Endpoint Determination
Hypogonadism -- drug therapy
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

118. Acne vulgaris: establishing effectiveness of drugs intended for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Acne Vulgaris -- drug therapy
Drug Evaluation -- standards
Clinical Trials as Topic -- standards
Endpoint Determination
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

119. Bioanalytical method validation

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Drug Evaluation, Preclinical -- standards
Reproducibility of Results
Research Design -- standards
Validation Studies as Topic
Biomarkers
Documentation
Dried Blood Spot Testing -- standards
Investigational New Drug Application
Quality Control
Reagent Kits, Diagnostic -- standards
Sensitivity and Specificity
Specimen Handling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

120. Enforcement policy--OTC sunscreen drug products marketed without an approved application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Health Policy
Marketing
Sunscreening Agents
Consumer Product Safety
Product Labeling
Sun Protection Factor
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

121. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

122. Complicated intra-abdominal infections: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
Drug Labeling -- standards
Endpoint Determination -- standards
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

123. Complicated urinary tract infections: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Anti-Infective Agents, Urinary -- therapeutic use
Clinical Trials as Topic -- standards
Drug Evaluation
Microbiological Techniques -- standards
Urinary Tract Infections -- drug therapy
Endpoint Determination -- standards
Research Design -- standards
Urinary Tract Infections -- complications
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

124. Medical product communications that are consistent with the FDA-required labeling: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Communication
Drug Labeling -- standards
Product Labeling -- standards
Equipment and Supplies -- standards
Pharmaceutical Preparations -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

125. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

126. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, June 15, 2018
Subject(s):: Electronic Health Records
Health Information Interoperability
Logical Observation Identifiers Names and Codes
Reagent Kits, Diagnostic
Device Approval
In Vitro Techniques -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

127. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

128. Assessing user fees under the biosimilar user fee amendments of 2017

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Biosimilar Pharmaceuticals -- economics
Fees and Charges
Investigational New Drug Application -- economics
Drug Evaluation -- economics
Parenteral Nutrition Solutions -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

129. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

130. Revised recommendations for reducing the risk of Zika virus transmission by blood and blood components

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, July 2018
Subject(s):: Blood Component Transfusion
Blood Safety -- standards
Blood Transfusion
Zika Virus Infection -- blood
Zika Virus Infection -- transmission
Blood Donors
Zika Virus Infection -- epidemiology
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

131. E17 general principles for planning and design of multiregional clinical trials

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Research Design
Demography
Endpoint Determination
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

132. Use of electronic health record data in clinical investigations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Clinical Trials as Topic
Electronic Health Records -- utilization
Health Information Interoperability
Forms and Records Control
Informed Consent
Reproducibility of Results
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

133. Labeling for biosimilar products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Biosimilar Pharmaceuticals
Drug Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

134. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):: Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

135. Extension of certain tobacco product compliance deadlines related to the final deeming rule: (revised)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Product Labeling -- standards
Tobacco Products -- standards
Tobacco Industry -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

136. Elemental impurities in drug products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Contamination
Quality Control
International Cooperation
Investigational New Drug Application
Reproducibility of Results
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

137. Dissolution testing and acceptance criteria for immediate-release solid oral dosage form drug products containing high solubility drug substances

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Liberation
Solubility
Dosage Forms
Therapeutic Index, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

138. Quality attribute considerations for chewable tablets

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Chemistry, Pharmaceutical
Drug Liberation
Mastication
Quality Control
Solubility
Tablets -- pharmacokinetics
Drug Approval
Drug Labeling
Hardness
Therapeutic Equivalency
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

139. Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Drug Evaluation, Preclinical
Radiopharmaceuticals -- administration & dosage
Radiopharmaceuticals -- pharmacokinetics
Diagnostic Imaging
Diagnostic Uses of Chemicals
Radiopharmaceuticals -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

140. Physiologically based pharmacokinetic analyses--format and content

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):: Drug Evaluation, Preclinical
Drugs, Investigational -- pharmacokinetics
Investigational New Drug Application
Research Design
Software
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

141. Allergic rhinitis: developing drug products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

142. Nonallergic rhinitis: developing drug products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Rhinitis -- drug therapy
Adult
Chemistry, Pharmaceutical
Child
Patient Selection
Pediatrics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

143. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):: Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

144. How CBO and JCT analyze major proposals that would affect health insurance coverage

Publication:: [Washington, DC] : Congressional Budget Office, February 2018
Subject(s):: Insurance Coverage -- economics
Insurance Coverage -- legislation & jurisprudence
Insurance, Health -- economics
Insurance, Health -- legislation & jurisprudence
Budgets
Costs and Cost Analysis
Federal Government
Health Benefit Plans, Employee -- economics
Health Benefit Plans, Employee -- legislation & jurisprudence
Income Tax
Medicaid -- economics
Models, Economic
State Government
Taxes
Humans
United States
United States.

145. Prices for and spending on specialty drugs in Medicare Part D and Medicaid: an in-depth analysis

Author(s):: Anderson-Cook, Anna, author
Maeda, Jared, author
Nelson, Lyle, author
Publication:: [Washington, DC] : Congressional Budget Office, March 2019
Subject(s):: Health Expenditures -- statistics & numerical data
Health Expenditures -- trends
Medicaid -- economics
Medicare Part D -- economics
Prescription Drugs -- economics
Drug Costs
Economics, Pharmaceutical -- trends
Forecasting
Medicaid -- trends
Medicare Part D -- trends
Orphan Drug Production -- economics
Humans
United States

146. Prices for and spending on specialty drugs in Medicare Part D and Medicaid

Publication:: [Washington, DC] : Congressional Budget Office, March 2019
Subject(s):: Health Expenditures -- statistics & numerical data
Health Expenditures -- trends
Medicaid -- economics
Medicare Part D -- economics
Prescription Drugs -- economics
Drug Costs
Economics, Pharmaceutical -- trends
Forecasting
Medicaid -- trends
Medicare Part D -- trends
Orphan Drug Production -- economics
Humans
United States

147. How do changes in Medical malpractice liability laws affect health care spending and the federal budget?

Author(s):: Stockley, Karen, author
Publication:: [Washington, DC] : Congressional Budget Office, April 2019
Subject(s):: Health Expenditures -- legislation & jurisprudence
Health Expenditures -- statistics & numerical data
Liability, Legal -- economics
Medicaid -- economics
Medicare -- economics
Models, Economic
Private Sector
Public Sector
Humans
United States

148. Social Security replacement rates and other benefit measures: an in-depth analysis

Publication:: [Washington, DC] : Congressional Budget Office, April 2019
Subject(s):: Social Security -- economics
Social Security -- statistics & numerical data
Social Security -- trends
Forecasting
Income
Retirement -- economics
Taxes
Humans
United States

149. Health insurance coverage for people under age 65: definitions and estimates for 2015 to 2018

Publication:: [Washington, DC] : Congressional Budget Office, April 2019
Subject(s):: Insurance Coverage -- statistics & numerical data
Insurance Coverage -- trends
Insurance, Health -- statistics & numerical data
Insurance, Health -- trends
Adolescent
Adult
Child
Forecasting
Health Benefit Plans, Employee -- statistics & numerical data
Infant
Middle Aged
Private Sector
Public Sector
Humans
United States
State Children's Health Insurance Program (U.S.)

150. Sources and preparation of data used in HISIM2: CBO’s health insurance simulation model

Author(s):: Banthin, Jessica, author
Kim, Geena, author
Hendel, Keren, author
Minicozzi, Alexandra, author
Hopkins, Ben, author
Malloy, Eamon, author
Percy, Allison, author
Publication:: [Washington, DC] : Congressional Budget Office, April 2019
Subject(s):: Insurance, Health
Models, Theoretical
Consumer Behavior
Cost Sharing
Demography
Eligibility Determination
Employment
Health Benefit Plans, Employee
Income
Medicaid
Humans
United States

151. Key design components and considerations for establishing a single-payer health care system

Publication:: [Washington, DC] : Congressional Budget Office, May 2019
Subject(s):: Insurance, Health, Reimbursement
Single-Payer System -- organization & administration
Universal Health Insurance
Health Care Reform
Insurance Coverage
Insurance, Health -- organization & administration
Humans
United States

152. Key design components and considerations for establishing a single-payer health care system: testimony before the Committee on the Budget, United States House of Representatives

Publication:: [Washington, DC] : Congressional Budget Office, May 22, 2019
Subject(s):: Insurance, Health, Reimbursement
Single-Payer System -- organization & administration
Universal Health Insurance
Cost Sharing
Health Care Reform
Health Services Accessibility
Insurance Coverage
Insurance, Health -- organization & administration
Humans
United States

153. Federal mandatory spending for means-tested programs: 2009 to 2029

Publication:: [Washington, DC] : Congressional Budget Office, June 2019
Subject(s):: Financing, Government -- economics
Financing, Government -- trends
Mandatory Programs -- economics
Mandatory Programs -- trends
Public Assistance -- economics
Public Assistance -- trends
Budgets
Eligibility Determination
Forecasting
Income
Government Programs -- economics
Government Programs -- trends
Humans
United States

154. The 2019 long-term budget outlook

Publication:: [Washington, DC] : Congressional Budget Office, June 2019
Subject(s):: Budgets -- trends
Gross Domestic Product -- trends
Demography
Federal Government
Forecasting
Medicare -- economics
Medicare -- trends
Social Security -- economics
Social Security -- trends
Humans
United States

155. Fourth partial report on Project no. 37 -- study of errors in field artillery practice: subject: an analysis of the sources of error in the use of the aiming circle and development of an improved instrument

Author(s):: Hatch, Theodore F., author
Brackett, Frederick S. (Frederick Sumner), 1896-1988, author
Horvath, Steven M., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 28 March 1945
Subject(s):: Military Personnel -- education
Weapons
Equipment and Supplies
United States

156. Report on Project no. 38 -- the military characteristics and design of observation telescope

Author(s):: Brackett, Frederick S. (Frederick Sumner), 1896-1988, author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 1 May 1945
Subject(s):: Telescopes
Military Personnel
United States

157. Japanese experiments in resistance to cold

Publication:: [Tokyo] : General Headquarters, Far East Command, Military Intelligence Dtachment, 1 August 1949
Subject(s):: Cold Injury -- prevention & control
Cold Injury -- physiopathology
Cold Temperature -- adverse effects
Stress, Physiological
Human Experimentation
Japan

158. Projecting demand for the services of primary care doctors:

Author(s):: Duchovny, Noelia, author
Trachtman, Sam, author
Werble, Ellen, author
Publication:: Washington, D.C. : Congressional Budget Office, May 2017
Subject(s):: Health Services Needs and Demand -- statistics & numerical data
Physicians, Family -- supply & distribution
Primary Health Care -- statistics & numerical data
Primary Health Care -- trends
Federal Government
Forecasting
Health Manpower -- statistics & numerical data
Health Manpower -- trends
Health Policy
Health Services Needs and Demand -- trends
Insurance Coverage
Insurance, Health, Reimbursement
Medicaid
Medicare
Physicians, Family -- education
Population Dynamics
Population Growth
Telemedicine
Humans
United States

159. Longer-term effects of the Better Care Reconciliation Act of 2017 on Medicaid spending

Publication:: Washington, D.C. : Congressional Budget Office, June 2017
Subject(s):: Health Care Reform -- economics
Health Care Reform -- legislation & jurisprudence
Medicaid -- economics
Medicaid -- legislation & jurisprudence
Capitation Fee
Forecasting
Medicaid -- statistics & numerical data
Medicaid -- trends
Humans
United States

160. Observations with AGF Task Forces Frigid and Williwaw

Author(s):: Molnar, G. W. (George W.)
Publication:: Fort Knox, Ky. : Medical Department Field Research Laboratory, 1948
Subject(s):: Cold Temperature
Adaptation, Physiological -- physiology
Cold Climate
World War II
Alaska

161. MEDLARS and health information policy

Publication:: Washington, D.C. : Congress of the United States, Office of Technology Assessment, September 1982
Subject(s):: MEDLARS
Health Information Management
Abstracting and Indexing as Topic
Information Storage and Retrieval
Automatic Data Processing
United States

162. Report on Project no. 36 -- treatment of mess kits to remove glare

Author(s):: Nelson, Norton A., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 6 May 1944
Subject(s):: Aluminum -- analysis
Glare
Cooking and Eating Utensils
United States

163. First partial report on Project, AMRL no. 37 and NDRC no. SOS-11 -- study of errors in field artillery practice

Author(s):: Hatch, Theodore F., author
Horvath, Steven M., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 18 September 1944
Subject(s):: Military Personnel -- education
Weapons
United States

164. Third partial report on Project no. 37 -- study of errors in field artillery practice: subject: analysis of requirements for eliminating errors in laying guns in elevation

Author(s):: Hatch, Theodore F., author
Brackett, Frederick S. (Frederick Sumner), 1896-1988. author
Horvath, Steven M., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 6 April 1945
Subject(s):: Military Personnel -- education
Weapons
United States

165. Final report on Project: AMRL no. 37 -- study of errors in field artillery practice

Author(s):: Hatch, Theodore F., author
Brackett, Frederick S. (Frederick Sumner), 1896-1988, author
Horvath, Steven M., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 13 June 1945
Subject(s):: Military Personnel -- education
Weapons
Equipment and Supplies
United States

166. Report on Project no. 40 -- military characteristics of spectacle-type binoculars

Author(s):: Brackett, Frederick S. (Frederick Sumner), 1896-1988, author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 30 May 1944
Subject(s):: Telescopes
Military Personnel
United States

167. First partial report on project no. 41 -- physiological characteristics of the T25E1-T26E1 tank: subject: control of gun fume hazard

Author(s):: Hatch, Theodore F., author
Nelson, Norton A., author
Lawson, Glasselle S., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 19 July 1944
Subject(s):: Carbon Monoxide Poisoning
Air Pollution, Indoor
Weapons
United States

168. Final report on Project no. 41 -- physiological and operational characteristics of tank T25E1

Author(s):: Brackett, Frederick S. (Frederick Sumner), 1896-1988, author
Roberts, Lester B., author
Nelson, Norton A., author
Walpole, Robert H., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 8 November 1944
Subject(s):: Weapons
Equipment and Supplies -- standards
Military Personnel
United States

169. Final report on Project no. 44 -- physiological and operational characteristics of M-24 tank

Author(s):: Brackett, Frederick S. (Frederick Sumner), 1896-1988, author
Roberts, Lester B., author
Nelson, Norton A., author
Walpole, Robert H., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 8 Novermber 1944
Subject(s):: Equipment and Supplies
Weapons
Ventilation
United States

170. Report on Project no. 42 -- letter report on test of pack, field, cargo; pack, field, combat; and suspenders, pack, field, cargo and combat

Author(s):: Freedman, Arthur, author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 29 August 1944
Subject(s):: Equipment and Supplies
Military Personnel
United States

171. First partial report on Project no. 45 -- physiological and operational characteristics of T26E3 tank

Author(s):: Brackett, Frederick S. (Frederick Sumner), 1896-1988, author
Nelson, Norton A., author
Roberts, Lester B., author
Mann, Wendell E., author
Walpole, Robert H., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 28 February 1945
Subject(s):: Equipment and Supplies
Weapons
Ventilation
United States

172. Second partial report on Project no. 45 -- operation and physiological characteristics of the tank T26E3: subject: the physiological work rates of the driver and loader in the tank T26E3 in relation to fatigue and efficiency of performances

Author(s):: Park, Charles R., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 19 June 1945
Subject(s):: Fatigue
Task Performance and Analysis
Weapons
United States

173. Final report on Project no. 45 -- operational and physiological characteristics of the tank T26E3, (M26): subject: the study of the proposed relocation of the 1000 CFM tank ventilating blower to the turret bulge

Author(s):: Walpole, Robert H., author
Nelson, Norton A., author
Palmes, Edward D., author
Publication:: Fort Knox, Kentucky : Armored Medical Research Laboratory, 31 July 1945
Subject(s):: Equipment and Supplies
Weapons
Ventilation
United States

174. An analysis of private-sector prices for hospital admissions

Author(s):: Maeda, Jared Lane, author
Nelson, Lyle, author
Publication:: [Washington, D.C.] : Congressional Budget Office, April 2017
Subject(s):: Hospital Costs -- statistics & numerical data
Insurance, Health, Reimbursement
Medicare -- economics
Medicare Part C -- economics
Private Sector
Diagnosis-Related Groups
Fee-for-Service Plans -- economics
Health Expenditures -- statistics & numerical data
Reimbursement Mechanisms
Humans
United States

175. Food Safety: a national strategy is needed to address fragmentation in federal oversight : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):: Food Safety
Food Supply
Government Regulation
Interinstitutional Relations
Federal Government
Public Health
Humans
United States
United States. Department of Agriculture.
United States. Food and Drug Administration.

176. Medicaid: CMS needs better data to monitor the provision of and spending on personal care services : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):: Community Health Services -- economics
Data Collection
Health Expenditures
Home Care Services -- economics
Long-Term Care -- economics
Medicaid -- economics
Humans
United States
Centers for Medicare & Medicaid Services (U.S.)

177. Medicaid managed care: improved oversight needed of payment rates for long-term services and supports : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):: Community Health Services -- economics
Insurance, Health, Reimbursement -- economics
Long-Term Care -- economics
Managed Care Programs -- economics
Medicaid -- economics
Data Collection
Government Regulation
State Government
Humans
United States
Centers for Medicare & Medicaid Services (U.S.)

178. Foster care: HHS has taken steps to support states' oversight of psychotropic medications, but additional assistance could further collaboration : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):: Child Welfare
Drug Utilization -- statistics & numerical data
Foster Home Care
Inappropriate Prescribing -- prevention & control
Psychotropic Drugs -- therapeutic use
Child
Government Regulation
Information Dissemination
Interinstitutional Relations
State Government
Humans
United States
United States. Department of Health and Human Services.

179. Medicaid: program oversight hampered by data challenges, underscoring need for continued improvements : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, January 2017
Subject(s):: Data Collection
Insurance, Health, Reimbursement
Medicaid -- economics
Government Regulation
State Government
Humans
United States
Centers for Medicare & Medicaid Services (U.S.)

180. Defense civil support: DOD, HHS, and DHS should use existing coordination mechanisms to improve their pandemic preparedness : report to the Committee on Armed Services, House of Representatives

Publication:: Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):: Civil Defense
Interinstitutional Relations
Pandemics
Disaster Planning
Federal Government
Humans
United States
United States. Department of Defense.
United States. Department of Health and Human Services.
United States. Department of Homeland Security.

181. Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):: Device Approval
Equipment Safety
Morcellation -- adverse effects
Morcellation -- instrumentation
Product Labeling
Leiomyoma -- surgery
Uterine Neoplasms -- surgery
Humans
United States
United States. Food and Drug Administration

182. Drug-free community support program: agencies have strengthened collaboration but could enhance grantee compliance and performance monitoring : report to Congressional committees

Publication:: Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):: Community Health Services
Community-Institutional Relations
Interinstitutional Relations
Substance-Related Disorders -- prevention & control
Adolescent
Financing, Government
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.

183. Federal disaster assistance: FEMA's progress in aiding individuals with disabilities could be further enhanced : report to Congressional requesters

Publication:: Washington, D.C. : U.S. Government Accountability Office, February 2017
Subject(s):: Disabled Persons
Disaster Planning
Adult
Child
Cyclonic Storms
Federal Government
State Government
Humans
United States
United States. Federal Emergency Management Agency.

184. The effects of terminating payments for cost-sharing reductions

Publication:: Washington, D.C. : Congressional Budget Office, 2017
Subject(s):: Cost Sharing -- economics
Deductibles and Coinsurance -- economics
Health Insurance Exchanges -- economics
Insurance Coverage -- statistics & numerical data
Insurance, Health -- statistics & numerical data
Budgets
Federal Government
Income Tax
Poverty
Humans
United States
United States.

185. Out-of-pocket expenditures for adults with health care expenses for multiple chronic conditions, U.S. civilian noninstitutionalized population, 2014

Author(s):: Soni, Anita, author
Publication:: Rockville, MD : Agency for Healthcare Research and Quality, February 2017
Subject(s):: Chronic Disease -- economics
Comorbidity
Health Expenditures -- statistics & numerical data
Adult
Aged
Continental Population Groups
Ethnic Groups
Health Care Surveys
Income
Insurance Coverage
Insurance, Health
Humans
United States
Medical Expenditure Panel Survey (U.S.)

186. Trends in enrollment, offers, eligibility and take-up for employer-sponsored insurance: private sector, by state Medicaid expansion status, 2008-2015

Author(s):: Cooper, Phil, author
Davis, Karen, author
Miller, G. Edward, author
Publication:: Rockville, MD : Agency for Healthcare Research and Quality, February 2017
Subject(s):: Eligibility Determination
Health Benefit Plans, Employee -- statistics & numerical data
Health Benefit Plans, Employee -- trends
Health Benefit Plans, Employee -- utilization
Medicaid
Forecasting
Health Care Surveys
Private Sector
State Government
Humans
United States
United States.
Medical Expenditure Panel Survey (U.S.)

187. Emergency use authorization of medical products and related authorities: guidance for industry and other stakeholders

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, January 2017
Subject(s):: Civil Defense -- legislation & jurisprudence
Device Approval
Drug Approval
Emergencies
Terrorism
Emergency Medical Services
Equipment Safety
Off-Label Use
Public Health
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Department of Homeland Security.
United States. Food and Drug Administration.

188. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:: Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):: Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

189. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

190. Q3C--tables and list

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, [June 2017]
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Compounding -- standards
Solvents -- classification
Congresses as Topic
International Cooperation
Solvents -- adverse effects
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

191. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Clinical Trials as Topic -- standards
Human Experimentation -- standards
Informed Consent -- standards
Ethics Committees, Research
Ethics, Research
Informed Consent -- ethics
Research Subjects
Risk
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

192. M4E(R2): the CTD--efficacy

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Investigational New Drug Application
Drugs, Investigational
Clinical Trials as Topic
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

193. Federal subsidies for health insurance coverage for people under age 65: 2017 to 2027

194. Consumer antiseptic wash final rule: questions and answers : (Small Entity Compliance Guide)

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Anti-Infective Agents, Local
Consumer Product Safety
Hand Sanitizers
Nonprescription Drugs
Anti-Bacterial Agents
Anti-Infective Agents, Local -- adverse effects
Soaps
Triclosan
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

195. Generic Drug User Fee Amendments of 2012: questions and answers related to self-identification of facilities, review of generic drug submissions, and inspections and compliance

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
Subject(s):: Drug Approval
Drug Industry -- standards
Drugs, Generic
Guideline Adherence
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

196. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

197. FY 2018 medical device user fee small business qualification and certification: guidance for industry, Food and Drug Administration staff and foreign governments

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 29, 2017
Subject(s):: Device Approval
Small Business
Eligibility Determination
Taxes
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

198. Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, August 31, 2017
Subject(s):: Equipment and Supplies
Equipment Safety
Evidence-Based Medicine
Product Surveillance, Postmarketing
Data Collection
Data Interpretation, Statistical
Decision Making
Device Approval
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

199. Procedures for meetings of the Medical Devices Advisory Committee: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 1, 2017
Subject(s):: Advisory Committees -- organization & administration
Device Approval
Equipment and Supplies -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

200. Design considerations and pre-market submission recommendations for interoperable medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 6, 2017
Subject(s):: Equipment and Supplies -- standards
Equipment Design -- standards
Equipment Safety -- standards
Device Approval
Equipment Failure
Information Dissemination
Risk Management
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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