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201. 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

202. 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

203. 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

204. 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

205. 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

206. 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

207. FDA could take stronger enforcement action against tobacco retailers with histories of sales to youth and other violations

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2023
Subject(s):: Government Regulation
Health Policy
Tobacco Control
Tobacco Industry -- legislation & jurisprudence
United States
United States. Food and Drug Administration

208. The Food and Drug Administration needs to improve the premarket tobacco application review process for electronic nicotine delivery systems to protect public health

Publication:: [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, November 2023
Subject(s):: Electronic Nicotine Delivery Systems -- supply & distribution
Government Regulation
Tobacco Control -- legislation & jurisprudence
United States
United States. Food and Drug Administration

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