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

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191. Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

192. Informed consent. Guidance for IRBs, clinical investigators, and sponsors

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Ethics Committees, Research
Government Regulation
Informed Consent
Research Personnel
United States
United States. Food and Drug Administration

193. Waivers, exceptions, and exemptions from the requirements of section 582 of the Federal Food, Drug, and Cosmetic Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Government Regulation
Legislation, Drug
United States
United States. Food and Drug Administration
United States.

194. Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, July 27, 2023
Subject(s):: Contact Lens Solutions
Device Approval
Government Regulation
Hydrogen Peroxide
Product Labeling
United States
United States. Food and Drug Administration

195. CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):: Drug Industry
Government Regulation
Quality Control
Reference Standards
United States
United States. Food and Drug Administration

196. M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
Subject(s):: Carcinogens
Drug Contamination -- prevention & control
Drug Development
Drug Industry
Government Regulation
Mutagenicity Tests
Mutagens
United States
United States. Food and Drug Administration

197. Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):: Drug Approval
Legislation, Drug
United States
United States. Food and Drug Administration

198. FDA’s work with the tri-agency task force for emergency diagnostics helped labs implement COVID-19 tests

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):: Advisory Committees
COVID-19 Testing
Government Agencies
Government Regulation
Laboratories
United States
United States. Food and Drug Administration

199. FDA repeatedly adapted emergency use authorization policies to address the need for COVID-19 testing

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2022
Subject(s):: COVID-19 Testing
Device Approval
Government Regulation
United States
United States. Food and Drug Administration

200. FDA’s approach to overseeing online tobacco retailers needs improvement

Publication:: Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, December 2022
Subject(s):: Data Collection
Government Regulation
Tobacco Control
Tobacco Industry -- legislation & jurisprudence
Tobacco Products -- legislation & jurisprudence
Tobacco Products -- supply & distribution
United States
United States. Food and Drug Administration

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