Subjects: Pharmaceutical Preparations -- standards - Digital Collections - National Library of Medicine Search Results

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1. 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

2. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2017
Subject(s):: Documentation -- standards
Drug Approval
Congresses as Topic
European Union
International Cooperation
Pharmaceutical Preparations -- standards
Humans
Canada
Europe
Japan
Switzerland
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Medical product communications that are consistent with the FDA-required labeling: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Communication
Drug Labeling -- standards
Product Labeling -- standards
Equipment and Supplies -- standards
Pharmaceutical Preparations -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Observation sheet

Author(s):: American Pharmaceutical Association. Section on Scientific Papers, author.
Publication:: [Baltimore, Md.?] : American Pharmaceutical Association, [1894?]
Subject(s):: Pharmaceutical Preparations -- standards
Surveys and Questionnaires

5. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

6. Q3D(R2) elemental impurities

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Drug Contamination
Drug Industry
Elements
Government Regulation
Pharmaceutical Preparations -- standards
United States
United States. Food and Drug Administration

7. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
Drug Contamination
Drug Labeling -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. [Remedies for diabetes, gall stones, and heart conditions]

Publication:: 1910
Subject(s):: Pharmaceutical Preparations -- standards
Drug Labeling -- standards

9. Report of Willis G. Tucker, M.D., Ph. D, analyst of drugs: to Woolsey Johnson, M.D., chairman of the Sanitary Committee of the State Board of Health of New York

Author(s):: Tucker, Willis G. (Willis Gaylord), 1849-1922, author
Publication:: [Albany, N.Y.?] : [publisher not identified], [1886?]
Subject(s):: Pharmaceutical Preparations -- analysis
Pharmaceutical Preparations -- standards
New York

10. Wholesale distributor verification requirement for saleable returned drug product: compliance policy

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2019
Subject(s):: Commerce -- legislation & jurisprudence
Legislation, Drug
Pharmaceutical Preparations -- standards
Drug Labeling
Drug Packaging
Guideline Adherence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.