Subjects: Drug Industry and Pharmaceutical Preparations / Genre: Technical Report - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Industry ✖ Subjects Pharmaceutical Preparations ✖ Genre Technical Report ✖

1. Pharmacogenomics: a primer for policymakers

Publication:: Washington, D.C. : George Washington University, [2008]
Subject(s):: Genetic Testing
Insurance Coverage
Pharmacogenetics -- economics
Pharmacogenetics -- trends
Information Management
Cost-Benefit Analysis
Drug Industry
Health Policy
Health Services Accessibility
Health Services Research
Insurance, Pharmaceutical Services
Pharmaceutical Preparations
Pharmacogenetics -- ethics
Safety
Humans
United States

2. Adjusting for covariates in randomized clinical trials for drugs and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Biological Products
Drug Industry
Government Regulation
Pharmaceutical Preparations
Randomized Controlled Trials as Topic
United States

3. 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.

4. S11 nonclinical safety testing in support of development of pediatric pharmaceuticals

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Drug Compounding
Drug Industry
Pediatrics
Pharmaceutical Preparations
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Nonclinical evaluation of the immunotoxic potential of pharmaceuticals: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Drug Evaluation, Preclinical
Drug Industry
Government Regulation
Pharmaceutical Preparations
Toxicity Tests
United States

6. Benefit-risk assessment for new drug and biological products: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, October 2023
Subject(s):: Biological Products
Drug Approval
Drug Industry
Drugs, Investigational
Government Regulation
Pharmaceutical Preparations
Risk Assessment
United States

7. Reformulating drug products that contain carbomers manufactured with benzene: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Benzene
Drug Compounding
Drug Industry
Government Regulation
Legislation, Drug
Pharmaceutical Preparations
United States

8. Real-world data: assessing registries to support regulatory decision-making for drug and biological products : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
Subject(s):: Biological Products
Data Collection
Decision Making
Drug Industry
Legislation, Drug
Government Regulation
Pharmaceutical Preparations
Registries
United States