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131. 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.

132. CT contrast media power injectors can rupture conventional IV sets

Publication:
[Harrisburg, Pa.] : Pennsylvania Patient Safety Authority, c2008
Subject(s):
Contrast Media
Cross Infection -- prevention & control
Equipment Failure
Injections, Intravenous -- instrumentation
Tomography, X-Ray Computed -- instrumentation
Equipment Safety
Guidelines as Topic
Pressure
Humans
Pennsylvania
United States
United States. Food and Drug Administration.

133. 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.

134. 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.

135. 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.

136. 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.

137. 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.

138. 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.

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