Collections: Health Policy and Services Research / Subjects: Drug Industry and Drug and Narcotic Control - Digital Collections - National Library of Medicine Search Results

Start Over Collections Health Policy and Services Research ✖ Subjects Drug Industry ✖ Subjects Drug and Narcotic Control ✖

1. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Industry
Drug and Narcotic Control
Pharmaceutical Preparations
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Drug Supply Chain Security Act implementation: identification of suspect product and notification

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
Subject(s):: Drug Industry
Drug and Narcotic Control
Security Measures
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Definitions of suspect product and illegitimate product for verification obligations under the Drug Supply Chain Security Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
Subject(s):: Drug Industry
Legislation, Drug
Drug Packaging
Drug and Narcotic Control
Government Regulation
United States

4. Enhanced drug distribution security at the package level under the Drug Supply Chain Security Act: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Drug Industry
Drug and Narcotic Control
Drug Packaging
Government Regulation
Security Measures
United States
United States.
United States.

5. Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Biological Products
Clinical Trials as Topic
Data Analysis
Decision Making
Drug Approval
Drug Industry
Drug and Narcotic Control
Government Regulation
United States
United States.

6. Wholesale distributor verification requirement for saleable returned drug product and dispenser verification requirements when investigating a suspect or illegitimate product: compliance policies : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023
Subject(s):: Counterfeit Drugs
Drug Industry
Drug and Narcotic Control
Fraud
Government Regulation
Substandard Drugs
United States
United States.