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Start Over Subjects Drugs, Investigational ✖Remove constraint Subjects: Drugs, Investigational Genre Guideline ✖Remove constraint Genre: Guideline

1. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):
Clinical Trials as Topic -- standards
Drug Evaluation -- standards
Muscular Dystrophies -- drug therapy
Muscular Dystrophy, Duchenne -- drug therapy
Drug Labeling -- standards
Drugs, Investigational
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff

Publication:
Silver Spring, MD : Food and Drug Administration, U.S. Department of Health and Human Services, June 2017
Subject(s):
Device Approval
Drug Approval
Investigational New Drug Application
Access to Information
Clinical Trials as Topic
Drugs, Investigational
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, September 2023
Subject(s):
Biological Products
Compassionate Use Trials
Drug Industry
Drugs, Investigational
Ethics Committees, Research
Government Regulation
United States