# Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/postmarketing-approaches-to-obtain-data-on-populations-underrepresented-in-clinical-trials-for-drugs-and-biological-products/46edf900-58f2-4f79-bf45-4baa56d25006

> FDA guidance document: Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products. Issue date: August 10, 2023. Get complete insights and analysis.

---

## Details

- Title: Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Office of the Commissioner
- Office URL: /offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424
- Issue Date: 2023-08-10
- Last Changed: 2023-08-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2022-D-2629 ">FDA-2022-D-2629 </a>

## Related Documents

- [Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/use-of-bayesian-methodology-in-clinical-trials-of-drug-and-biological-products-draft-guidance-for-industry/8e9c345e-0994-47b3-8d6c-054f04ed937e)
- [Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products](https://www.globalkeysolutions.net/guidances/guidance-document/meta-analyses-of-randomized-controlled-clinical-trials-to-evaluate-the-safety-of-human-drugs-or-biological-products/0ed49ff3-89c9-4436-8c06-0324d3e2aff2)
- [Approaches to Assessment of Overall Survival in Oncology Clinical Trials: Draft Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/approaches-to-assessment-of-overall-survival-in-oncology-clinical-trials-draft-guidance-for-industry/58214f23-534c-4277-9edd-e5f553d63680)
