Description
The process of implementing this section of FDAMA was logically divided into two stages. During the first stage, existing guidance was identified and evaluated to assess whether it was adequate, whether additional guidance was needed or whether there was insufficient information at this time to make such a determination. The outcome of this first stage would dictate whether another stage, which might include gathering additional data and drafting additional guidance, would be needed.
Scope & Applicability
Product Classes
1NMEs approved by CDER during 1995-1996 reviewed for demographic data
Stakeholders
4Inclusion of Women and Minorities as Subjects in Clinical Research
Inclusion of Women and Minorities as Subjects in Clinical Research
Ad hoc working group established to review guidance requirements
representation included in advisory committee meetings
Regulatory Context
Attributes
1Includes age group, sex, and race
Related CFR Sections (1)
Related Warning Letters (10)
- 2025-12-23
In Vivo Bioavailability-Bioequivalence Studies – Clinical
Maria A. Carballosa, M.D.
- 2025-12-09
Unapproved New Drug/Unlicensed Biological Product/Biologics License Application (BLA)
Celularity, Inc
- 2025-11-18
Sponsor/Investigator
Verdure Sciences, Inc.
- 2025-09-30
Clinical Investigator (Sponsor)
Pamela K. Den Besten, DDS, MS
- 2025-09-23
Clinical Investigator/Sponsor
Ralph A. DeFronzo, M.D.
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-07-01
Clinical Investigator
Peter Michael, M.D.
- 2025-06-10
Clinical Investigator (Sponsor)
American Behavioral Research Institute, LLC
- 2025-06-03
Bioresearch Monitoring Program
Amy Lightner, MD
See Also (8)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Format and Content of the Microbiology Section of an Application*: Guidance for Industry (Status: Final)
- Formatting, Assembling and Submitting New Drug and Antibiotic Applications* (Status: Final)
- Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (Status: Final)
- Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (Status: Final)
- Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications (Status: Final)
- Prussian Blue Drug Products — Submitting a New Drug Application (Status: Final)