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161. Extending expiration dates of doxycycline tablets and capsules in strategic stockpiles: guidance for government public health and emergency response stakeholders

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2019
Subject(s):
Anthrax -- drug therapy
Civil Defense
Doxycycline -- supply & distribution
Doxycycline -- therapeutic use
Post-Exposure Prophylaxis
Strategic Stockpile
Biological Availability
Drug Stability
Drug Storage
Legislation, Drug
Biological Availability
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

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

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Guideline Adherence
Tobacco Products -- adverse effects
Tobacco Products -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

164. FDA categorization of investigational device exemption (IDE) devices to assist the Centers for Medicare and Medicaid Services (CMS) with coverage decisions: guidance for sponsors, clinical investigators, industry, institutional review boards, and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, December 5, 2017
Subject(s):
Device Approval
Equipment and Supplies
Insurance Coverage
Medicare -- economics
Therapies, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
Centers for Medicare & Medicaid Services (U.S.)

165. FDA deems certain tobacco products subject to FDA authority, sales and distribution restrictions, and health warning requirements for packages and advertisements: (revised)

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019
Subject(s):
Commerce -- legislation & jurisprudence
Product Labeling -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- supply & distribution
Advertising -- legislation & jurisprudence
Tobacco Products -- adverse effects
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

167. FDA should further integrate its review of cybersecurity into the premarket review process for medical devices

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2018
Subject(s):
Computer Security
Device Approval -- standards
Equipment and Supplies -- standards
Equipment Safety -- standards
Computer Communication Networks -- standards
Guidelines as Topic
Software -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

168. 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.

170. Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications: guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019
Subject(s):
Cost-Benefit Analysis
Device Approval
Equipment and Supplies -- classification
Equipment Safety -- classification
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

171. Federal Medicaid policy

Author(s):
Raduege, Tammy J., author
Publication:
[Toronto, Ontario] : Thomson Reuters, 23-December-2019
Subject(s):
Medicaid -- organization & administration
Federal Government
Health Policy
Community Health Services -- legislation & jurisprudence
Eligibility Determination -- legislation & jurisprudence
Healthcare Disparities -- legislation & jurisprudence
Home Care Services -- legislation & jurisprudence
Managed Care Programs -- legislation & jurisprudence
Medicaid -- legislation & jurisprudence
Mental Health Services -- legislation & jurisprudence
Reproductive Health Services -- legislation & jurisprudence
Rural Health Services -- legislation & jurisprudence
Social Support
Humans
United States
United States. Department of Health and Human Services.
United States.
Centers for Medicare & Medicaid Services (U.S.)

172. A few states fell short in timely investigation of the most serious nursing home complaints: 2011-2015

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
Subject(s):
Nursing Homes
Quality Assurance, Health Care
Aged
Elder Abuse
State Government
Time Factors
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

173. Followup review: CMS's management of the quality payment program

Publication:
[Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, December 2017
Subject(s):
Insurance, Health, Reimbursement
Medical Informatics
Medicare Part B -- economics
Quality of Health Care -- economics
Reimbursement, Incentive
Diffusion of Innovation
Fraud -- prevention & control
Humans
United States
United States. Department of Health and Human Services.
Centers for Medicare & Medicaid Services (U.S.)

174. Food labeling: serving sizes of foods that can reasonably be consumed at one eating occasion, reference amounts customarily consumed, serving size-related issues, dual-column labeling, and miscellaneous topics

Publication:
Silver Spring, MD : Food and Drug Administration, Center for Food Safety and Applied Nutrition, December 2019
Subject(s):
Diet, Healthy
Food Labeling -- standards
Portion Size -- standards
Product Labeling -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

175. 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.

176. Formal dispute resolution: sponsor appeals above the division level : guidance for industry and review staff : good review practice

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Dissent and Disputes
Investigational New Drug Application
Negotiating
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

177. 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.

178. Further testing of donations that are reactive on a licensed donor screening test for antibodies to hepatitis C virus

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, October 2019
Subject(s):
Blood -- virology
Blood Banks -- standards
Blood Donors
Hepatitis C -- blood
Hepatitis C -- transmission
Donor Selection
Hepatitis C Antibodies -- blood
Nucleic Acid Amplification Techniques
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

179. Gauging the progress of the National Health Information Technology Initiative: perspectives from the field

Publication:
Oakland, Calif. : California HealthCare Foundation, c2008
Subject(s):
Diffusion of Innovation
Medical Informatics -- trends
Medical Records Systems, Computerized -- trends
Program Evaluation
Federal Government
Forecasting
Government Programs
Medical Informatics -- economics
Medical Informatics -- legislation & jurisprudence
Medical Informatics -- standards
Medical Records Systems, Computerized -- economics
Medical Records Systems, Computerized -- legislation & jurisprudence
Medical Records Systems, Computerized -- standards
Privacy
State Government
Humans
United States
United States. Department of Health and Human Services.
United States.

180. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.