ASH | FDA Collaboration: A Workshop on Regulatory Science in Hematology

ASH is committed to educating its members about the U.S. Food and Drug Administration (FDA) and regulatory science. The ASH-FDA regulatory science workshop is geared for active hematology/oncology fellows, physicians, and researchers with an interest in clinical or translational research, drug development, or regulatory science. Regulatory science is the science of developing and applying new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products across the product lifecycle.

This two-day, in-person workshop at ASH Headquarters in Washington, DC will feature engaging panel discussions, case-based breakout groups, roundtables, and networking with FDA physicians and scientists, fostering collaboration and knowledge exchange.

Information for the 2027 workshop will be available soon.

Workshop Goals

At the close of this interactive, multi-day workshop, participants will have a basic knowledge of the FDA’s role in hematology/oncology product development, including:

  • The Investigational New Drug (IND) process (what an IND is, when it is required, and what criteria are used by the FDA to decide if a research study may proceed).
  • Trial design for early-stage and late-stage clinical trials, including endpoint selection and patient population.
  • Expanded access programs (single patient INDs, emergency INDs, expanded access protocols).
  • Expedited development programs (e.g., breakthrough therapy designation, fast track designation).
  • Regulatory considerations when reviewing new drug applications, including the risk-benefit assessment of drugs and biologic products.

Eligibility Requirements

Applicants should have an interest in clinical or translational research, drug development, and/or regulatory science. Applicants currently in training must have completed at least one year of fellowship in an accredited U.S. training program and be in good standing. Applicants cannot be employed by a pharmaceutical company or industry. Applicants should be a current ASH member.

Application Requirements

A complete application must include a complete application form submitted through the ASH Awards Portal by April 20, 2026.

  • Explain why you want to participate in the Workshop
  • What do you hope to learn more about at the Workshop?
  • Describe your role in clinical trials.

Learn More!

Learn about the 2023 Workshop on ASH’s Podcast, The Hematologist

Questions?

For more information, contact ASH Government Relations & Public Health Specialist, Lilian Martinez-Orellana at lmorellana@hematology.org.