Donna C. Tran
- Role
- Regulatory Counsel at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Donna C. Tran
Senior legal and regulatory counsel with over a decade of experience advising FDA and CMS, offering deep expertise in policy development, legal analysis, regulatory compliance, and strategic implementation across the healthcare landscape—from a new FDA drug approval pathway and drug manufacturing quality improvement to Medicare payment, quality-of-care improvement, healthcare value-based purchasing, and innovative payment models.
Experience
Regulatory Counsel
Oct 2022 — Present
Center for Drug Evaluation and Research, Office of Regulatory PolicyLead Regulatory Counsel for FDA’s new drug approval pathway, Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU)(89 Fed. Reg. 105288), enabling certain prescription drugs to be marketed as nonprescription with appropriate safeguards.ORP SME on Quality Management Maturity initiatives
Education
The University of Texas at Austin
B.S.
Saint Louis University School of Law
J.D.
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