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Start Over Collections Health Policy and Services Research ✖ Subjects Biological Products ✖

1. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):: Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Mixing, diluting, or repackaging biological products outside the scope of an approved biologics license application

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2018
Subject(s):: Biological Products
Drug Approval
Drug Packaging
Prescription Drugs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. M10: bioanalytical method validation and study sample analysis : guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, November 2022
Subject(s):: Biological Products
Chemistry Techniques, Analytical
Government Regulation
Methods
United States
United States. Food and Drug Administration

4. 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

5. 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

6. Submitting documents using real-world data and real-world evidence to FDA for drug and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
Subject(s):: Biological Products
Drug Development
Government Regulation
Pragmatic Clinical Trials as Topic
United States
United States. Food and Drug Administration

7. General clinical pharmacology considerations for neonatal studies for drugs and biological products

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Clinical Studies as Topic
Drug Development
Government Regulation
Infant Health
Pharmacology, Clinical
United States
United States. Food and Drug Administration

8. Instructions for use: patient labeling for human prescription drug and biological products : content and format

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Biological Products
Government Regulation
Prescription Drugs
Product Labeling
United States
United States. Food and Drug Administration

9. Comparability Protocols for postapproval changes to the chemistry, manufacturing, and controls information in an NDA, ANDA, or BLA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biological Products
Drug Approval
Government Regulation
United States
United States. Food and Drug Administration

10. 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