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Start Over Formats Text ✖Remove constraint Formats: Text Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Genre Technical Report ✖Remove constraint Genre: Technical Report Copyright Public domain ✖Remove constraint Copyright: Public domain

121. Requirements for transactions with first responders under section 582 of the Federal Food, Drug, and Cosmetic Act--compliance policy

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2017
Subject(s):
Emergency Medical Services -- legislation & jurisprudence
Emergency Responders -- legislation & jurisprudence
Pharmaceutical Preparations -- supply & distribution
Drug Therapy
Legislation, Drug
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

122. Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2017
Subject(s):
Automatic Data Processing -- standards
Investigational New Drug Application
Drug Approval -- legislation & jurisprudence
Drug Approval -- organization & administration
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

123. Memory supplements: clarifying FDA and FTC roles could strengthen oversight and enhance consumer awareness : report to Congressional requesters

Publication:
Washington, D.C. : U.S. Government Accountability Office, May 2017
Subject(s):
Dietary Supplements
Drug and Narcotic Control
Government Regulation
Marketing of Health Services
Memory -- drug effects
Memory Disorders -- drug therapy
Advertising as Topic
Commerce
Internet
Humans
United States
United States. Federal Trade Commission.
United States. Food and Drug Administration.

124. Generic drug user fees: application review times declined, but FDA should develop a plan for administering its unobligated user fees : report to the Chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate

Publication:
Washington, D.C. : U.S. Government Accountability Office, May 2017
Subject(s):
Drugs, Generic -- economics
Drugs, Investigational -- economics
Investigational New Drug Application -- economics
Drug Approval -- economics
Humans
United States
United States. Food and Drug Administration.

125. Investigational new drugs: FDA has taken steps to improve the expanded access program but should further clarify how adverse events data are used : report to Congressional addressees

Publication:
Washington, D.C. : U.S. Government Accountability Office, July 2017
Subject(s):
Adverse Drug Reaction Reporting Systems
Drugs, Investigational -- adverse effects
Drugs, Investigational -- therapeutic use
Drug Approval
Health Services Accessibility
Humans
United States
United States. Food and Drug Administration.

126. Investigational new drugs: FDA's expanded access program : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives

Publication:
Washington, D.C. : U.S. Government Accountability Office, October 3, 2017
Subject(s):
Drug Approval -- statistics & numerical data
Drugs, Investigational -- therapeutic use
Health Services Accessibility
Patient Safety
Investigational New Drug Application
Humans
United States
United States. Food and Drug Administration.

127. Imported seafood safety: FDA and USDA could strengthen efforts to prevent unsafe drug residues : report to the chairman, Committee on Appropriations, U.S. Senate

Publication:
Washington, DC : United States Government Accountability Office, September 2017
Subject(s):
Anti-Bacterial Agents -- adverse effects
Commerce -- standards
Drug Residues -- standards
Fishes
Food Contamination -- prevention & control
Food Safety
Food Supply -- standards
Hazard Analysis and Critical Control Points
Seafood
Aquaculture -- standards
Catfishes
Food Safety -- methods
Government Regulation
Public Health
Humans
Asia
Canada
United States
United States. Department of Agriculture.
United States. Food and Drug Administration.

128. Low-dose radiation: interagency collaboration on planning research could improve information on health effects : testimony before the Subcommittee on Energy, Committee on Science, Space, and Technology, House of Representatives

Publication:
Washington, DC : United States Government Accountability Office, November 1, 2017
Subject(s):
Government Agencies
Interinstitutional Relations
Radiation Effects
Radiation, Ionizing
Research
Radiation Dosage
Humans
United States
United States. Department of Energy.
United States. Environmental Protection Agency.
United States. Food and Drug Administration.
U.S. Nuclear Regulatory Commission.

131. FDA medical device reviews: evaluation is needed to assure requests for additional information follow a least burdensome approach : report to Congressional requestors

Publication:
Washington, DC : United States Government Accountability Office, December 2017
Subject(s):
Device Approval -- standards
Equipment Safety
Federal Government
Forecasting
Government Regulation
Inservice Training
Humans
United States
United States. Food and Drug Administration.

132. Generic drugs: FDA should make public its plans to issue and revise guidance on nonbiological complex drugs : report to Congressional requesters

Publication:
Washington, DC : United States Government Accountability Office, December 2017
Subject(s):
Drug Approval
Drugs, Generic
Therapeutic Equivalency
Chemistry, Pharmaceutical
Doxorubicin
Drug Development
Enoxaparin
Glatiramer Acetate
Gluconates
Propofol
Humans
United States
United States. Food and Drug Administration.

133. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

134. Enforcement policy for viral transport media during the Coronavirus disease 2019 (COVID-19) public health emergency: guidance for commercial manufacturers, clinical laboratories, and Food and Drug Administration staff

Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality, July 2020
Subject(s):
Culture Media
Specimen Handling
Transportation
Virus Diseases
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

135. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use : guidance for industry and Food and Drug Administration staff

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, July 2020
Subject(s):
Biological Products
Tissues
Cell- and Tissue-Based Therapy
Tissue Transplantation
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

136. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:
Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

138. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:
[Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):
Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

139. Marketing status notifications under Section 506I of the Federal Food, Drug, and Cosmetic Act: content and format

Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, August 2020
Subject(s):
Legislation, Drug
Legislation, Food
Marketing -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

140. Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization (revised)

Publication:
Silver Spring, MD : Center for Tobacco Products, April 2020
Subject(s):
Adolescent Behavior
Adolescent Health
Electronic Nicotine Delivery Systems
Vaping -- prevention & control
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.