Subjects: Government Regulation / Genre: Guideline - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Government Regulation ✖ Genre Guideline ✖

1. Action level for inorganic arsenic in apple juice: guidance for industry

Publication:: College Park, MD : Center for Food Safety and Applied Nutrition, June 2023
Subject(s):: Arsenic
Food Safety
Food Supply
Government Regulation
United States

2. Acute myeloid leukemia: developing drugs and biological products for treatment : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Development -- legislation & jurisprudence
Government Regulation
Leukemia, Myeloid, Acute -- drug therapy
United States
United States. Food and Drug Administration

3. 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

4. Alternative procedures for the manufacture of cold-stored platelets intended for the treatment of active bleeding when conventional platelets are not available or their use is not practical: guidance for industry

Publication:: Silver Spring, MD : Center for Biologics Evaluation and Research, June 2023
Subject(s):: Biological Products -- standards
Blood Platelets
Government Regulation
Platelet Transfusion
Refrigeration
United States

5. Annual status report information and other submissions for postmarketing requirements and commitments: using forms FDA 3988 and FDA 3989 : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):: Forms as Topic
Government Regulation
Product Surveillance, Postmarketing
United States
United States.
United States.

6. Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2023
Subject(s):: Government Regulation
Medical Device Legislation
Microbial Sensitivity Tests -- standards
Product Labeling
United States

7. Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff

Publication:: Silver Spring, MD : Center for Devices and Radiological Health, September 2023
Subject(s):: Bioengineering
Device Approval
Drug Development
Drug Industry
Ergonomics
Government Regulation
United States

8. Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, November 17, 2023
Subject(s):: Computer Simulation
Device Approval
Government Regulation
United States

9. Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2022
Subject(s):: Administration, Oral
Drug Approval
Drugs, Investigational
Food-Drug Interactions
Government Regulation
United States
United States. Food and Drug Administration

10. 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

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