Subjects: United States. Food and Drug Administration - Digital Collections - National Library of Medicine Search Results

Start Over Subjects United States. Food and Drug Administration ✖

81. Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Drug Approval
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

82. Review timelines for applicant responses to complete response letters when a facility assessment is needed during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Facility Regulation and Control
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

83. Drug safety: COVID-19 complicates already challenged FDA foreign inspection program : testimony before the Committee on Finance, U.S. Senate

Publication:: Washington, DC : United States Government Accountability Office, June 2, 2020
Subject(s):: Pharmaceutical Preparations -- supply & distribution
Drug Contamination -- legislation & jurisprudence
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration

84. Drug development: FDA's priority review voucher programs : report to Congressional committees

Publication:: Washington, DC : United States Government Accountability Office, January 2020
Subject(s):: Drug Approval -- organization & administration
Drug Development -- organization & administration
Rare Diseases -- drug therapy
United States
United States. Food and Drug Administration

85. Ownership--but not physical movement--of selected drugs can be traced through the supply chain

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, February 2020
Subject(s):: Prescription Drug Diversion -- prevention & control
Prescription Drugs -- supply & distribution
Counterfeit Drugs -- supply & distribution
United States
United States. Food and Drug Administration

86. FDA’s risk evaluation and mitigation strategies: uncertain effectiveness in addressing the opioid crisis

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2020
Subject(s):: Government Regulation
Opioid-Related Disorders -- economics
Risk Evaluation and Mitigation -- legislation & jurisprudence
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

87. Drug safety: preliminary findings indicate persistent challenges with FDA foreign inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives

Publication:: Washington, DC : United States Government Accountability Office, December 10, 2019
Subject(s):: Drug Industry -- legislation & jurisprudence
Government Regulation
Pharmaceutical Preparations -- standards
United States
United States. Food and Drug Administration

88. Generic drug development: stakeholders’ views of risk evaluation and mitigation strategies differ : report to the Chairman, Committee on Energy and Commerce, House of Representatives

Publication:: Washington, DC : United States Government Accountability Office, October 2019
Subject(s):: Drug Industry -- legislation & jurisprudence
Drugs, Generic -- isolation & purification
Government Regulation
Risk Evaluation and Mitigation -- legislation & jurisprudence
United States
United States. Food and Drug Administration

89. Referencing approved drug products in ANDA submissions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Approval
Drug Evaluation
Drug Labeling
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

90. Remote interactive evaluations of drug manufacturing and bioresearch monitoring facilities during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, April 2021
Subject(s):: Consumer Product Safety
Drug Industry
Pharmaceutical Research
COVID-19
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

« Previous
Next »
1
2
…
5
6
7
8
9
10
11
12
13
…
20
21