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  1. Center for Drug Evaluation and Research | CDER

Grail Sipes J.D.
Leadership Role
Deputy Center Director for Regulatory Policy - Center for Drug Evaluation and Research | CDER

Gail Sipes, J.D.
Grail Sipes J.D.

Grail Sipes is the Deputy Center Director for Regulatory Policy at FDA’s Center for Drug Evaluation and Research (CDER). In this position, Ms. Sipes is responsible for broad policy matters and issues in all areas related to human drugs. She serves as advisor to the Center Director and FDA officials on matters impacting drug policy development, execution, and long-range program goals. This Includes input on industry positions and proposals, precedent cases and other aspects of consumer protection and public health, proposed legislation, and implementation of regulations and standards related to drugs.

Previously, Ms. Sipes was the director of CDER’s Office of Regulatory Policy (ORP). In that role, she managed the development of new regulations and policies applicable to FDA’s regulation of human pharmaceuticals. She joined FDA in 2011 as a senior regulatory counsel in ORP. Before coming to FDA, she was in legal practice as a partner with Covington & Burling, LLP. Earlier in her career, she served with the NYC Human Resources Administration as a budget manager for foster care and preventive services for children. She also was an associate at Oliver, Wyman & Co., a strategy consulting firm in the financial services industry.

Ms. Sipes earned a bachelor’s degree from Yale University with distinction in literature, and her juris doctor degree from Harvard Law School.

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