NLM Digital Collections

Search

Start Over Subjects United States. Food and Drug Administration. ✖Remove constraint Subjects: United States. Food and Drug Administration. Publication Year 2017 ✖Remove constraint Publication Year: 2017

71. 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.

72. 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.

73. 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.

74. 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.

77. 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.

78. 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.

79. Implantable devices: regulatory framework and reform options

Author(s):
Lind, Keith D., author
Publication:
Washington, DC : AARP Public Policy Institute, August 2017
Subject(s):
Government Regulation
Prostheses and Implants -- adverse effects
Prostheses and Implants -- standards
Clinical Trials as Topic
Device Approval
Equipment Failure
Equipment Safety
Product Surveillance, Postmarketing
Registries
Humans
United States
United States. Food and Drug Administration.