Subjects: Drug Industry and United States / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drug Industry ✖ Subjects United States ✖ Genre Guideline ✖

1. Drug and device manufacturer communications with payors, formulary committees, and similar entities: questions and answers : guidance for industry and review staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):: Communication
Equipment and Supplies -- economics
Insurance, Health, Reimbursement -- economics
Pharmaceutical Preparations -- economics
Truth Disclosure
Costs and Cost Analysis
Device Approval
Drug Approval
Drug Industry
Information Dissemination
Outcome Assessment (Health Care) -- economics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2017
Subject(s):: Communication
Drug Industry
Investigational New Drug Application
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Format and content of a REMS document: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2023
Subject(s):: Biological Products
Consumer Product Safety -- legislation & jurisprudence
Drug Industry
Government Regulation
Risk Evaluation and Mitigation
United States
United States. Food and Drug Administration

4. 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

5. 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

6. Policy regarding N-acetyl-L-cysteine: guidance for industry

Publication:: College Park, MD : Center for Drug Evaluation and Research, August 2022
Subject(s):: Acetylcysteine
Drug Industry
Government Regulation
United States
United States. Food and Drug Administration

7. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Contamination
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Ethylene Glycols
Glycerol
Government Regulation
Propylene Glycol
Sorbitol
United States

8. Q9(R1): : quality risk management : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):: Drug Development
Drug Industry
Government Regulation
Risk Management
United States

9. 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

10. Evaluation of gastric pH-dependent drug interactions with acid-reducing agents: study design, data analysis, and clinical implications : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2023
Subject(s):: Drug Industry
Drug Interactions
Gastrointestinal Agents
Government Regulation
Hydrogen-Ion Concentration
United States