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Juan M. Hincapie-Castillo: FDA Releases Draft 2026 Guidance Plans Including Endometriosis-Associated Pain
Feb 28, 2026, 03:58

Juan M. Hincapie-Castillo: FDA Releases Draft 2026 Guidance Plans Including Endometriosis-Associated Pain

Juan M. Hincapie-Castillo, Associate Professor at University of Pittsburgh, shared a post on LinkedIn:

“The FDA Center for Drug Evaluation and Research released its New and Revised Draft Guidances Planned for Publication in CY 2026.

A few that stand out to me working in RWE, drug safety, and pain:

  • Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
  • Considerations for the Inclusion of Older Adults in Clinical Trials
  • Endometriosis-Associated Pain: Establishing Effectiveness and Safety of Drugs for Management
  • Sickle Cell Disease: Endpoints for the Development of Products for Prevention and Treatment of SCD Complications
  • Development of a Shared System or Separate REMS.”

Proceed to the pages attached to the post.

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