Description
This guidance provides recommendations for (1) increasing enrollment of female participants in clinical trials and non-interventional studies to help ensure the generalizability of results, (2) analyzing and interpreting sex-specific data, and (3) including sex-specific information in regulatory submissions of medical products. In areas where male participants may be underrepresented in clinical trials, the general principles outlined in this guidance also apply to increasing enrollment of male participants in clinical trials.
Scope & Applicability
Product Classes
2Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Clinical Trials Supporting FDA Approval of Cardiovascular Drugs
Stakeholders
2Entity responsible for submitting applications under section 524B
entity submitting marketing applications
Regulatory Context
Attributes
2Data element D.5 capturing the sex of the patient.
different recommended dosages in females and males
Identified Hazards
Hazards
2excluded from eligibility because of a risk or potential risk of reproductive or developmental toxicity
Specific risks associated with a drug that may necessitate ETASU
Related CFR Sections (5)
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
- 21CFR312.23§ 312.23 IND content and format.
(a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an “Investigational New Drug Application” (IND) including, in the following order:Read full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR312.33§ 312.33 Annual reports.
A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes:Read full regulation →
- 21CFR812.25§ 812.25 Investigational plan.
The investigational plan shall include, in the following order:Read full regulation →
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)
- Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (Status: Final)
- Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff (Status: Final)
- Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (Status: Final)
- Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff (Status: Final)
- Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff (Status: Final)
- Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry (Status: Draft)
- Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties (Status: Draft)