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Former FDA Associate Chief Counsel Anna Sims Joins Covington’s Life Sciences Practice
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Covington is pleased to announce that Anna Sims has joined Covington as Special Counsel in the firm’s Food, Drug, and Device practice group. Anna previously served as Associate Chief Counsel at the Food and Drug Administration (FDA) Office of Chief Counsel (OCC).
Utilizing her experience at the FDA, Anna provides strategic regulatory and policy advice on a wide range of complex matters for pharmaceutical and biotechnology clients. Her practice focuses on life-cycle management issues and related advocacy.
During her years as Associate Chief Counsel at FDA, Anna was Team Lead for OCC’s Hatch-Waxman Team and served as OCC’s Liaison to FDA’s Center for Drug Evaluation and Research’s (CDER) Exclusivity Board. She regularly advised FDA’s Office of Orphan Products Development (OOPD) on orphan-drug designation and exclusivity issues. She also regularly advised other offices within the agency, such as the Office of Generic Drugs (OGD) and Office of New Drugs (OND) on abbreviated new drugs applications (ANDAs) and 505(b)(2) applications, including approvability issues, 30-month stays, carve outs, exclusivity determinations, and citizen petitions. Her practice at the agency also included significant work on priority review vouchers and counseling on the Biologics Price Competition and Innovation Act, including issues related to reference product exclusivity and biosimilar
licensure standards.
We are delighted to have Anna at Covington. Her deep FDA regulatory experience elevates the capabilities we are able to offer our clients. We would be happy to arrange an introduction with Anna to discuss how her experience and insights can be helpful to your organization. |
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