CDER Announces Hire of New Top Regulatory Policy Official

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has announced the hire of a new permanent director of its Office of Regulatory Policy.

As Regulatory Focus reported earlier this year, CDER had been seeking a candidate for the office since at least February 2014, when it posted a job notice to federal job boards seeking someone with a legal background and experience developing, interpreting and implementing regulations, laws and policies.

That position will now be filled by Grail Sipes, announced Janet Woodcock, director of CDER, in an email to FDA staff on 15 September 2014.

Sipes has been with FDA since 2011, acting as a senior regulatory counsel in ORP, where she worked mostly on tobacco and nicotine-related issues. Prior to coming to FDA, Sipes was a partner at Covington & Burling, LLP, where she worked on human drug and biologic regulatory and legal issues.

"With her extensive ORP experience and legal knowledge, Grail has demonstrated a notable ability to analyze complex statutory and regulatory issues," Woodcock wrote. "I look forward to working with her in advancing the priorities of the Department in the development of policies related to human drugs."

Sipes will replace ORP Acting Director Nancy Hayes, and will begin on 22 September 2014.