Catherine Morales, PharmD

Regulatory Health Project Manager, ORO, DPM, OGD, CDER

Catherine is a Regulatory Project Manager within the Division of Project Management (DPM), Office of Regulatory Operations (ORO), Office of Generic Drugs (OGD).  She joined the FDA in 2020 after working for 15 years as a clinical research project manager for government (e.g., NIH) and privately (e.g., industry) funded Phase I-IV clinical trials for both drugs and medical devices.  Catherine’s primary role at the FDA is to oversee and coordinate the review lifecycle of Abbreviated New Drug Applications (ANDAs) and serve as the primary contact to both internal and external stakeholders for all things related to ANDAs under her portfolio.  Catherine graduated with a B.A. from the University of Iowa.

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