CDER Announces Hire of Top Compliance Official

Regulatory News

The US Food and Drug Administration (FDA) has announced the hire of a new senior official, Cynthia Schnedar, who will serve as the director of the Center for Drug Evaluation and Research's (CDER) Office of Compliance (OC), its drug compliance enforcement division.

The position had been vacated earlier this year by Howard Sklamberg, who had served as director of CDER's OC since November 2012. In January 2014, Sklamberg was promoted to the position of deputy commissioner for Global Regulatory Operations and Policy (GO), leaving the position without a permanent director.

Schnedar, the new hire, had most recently been a part of the Department of Justice, where she served as the deputy inspector general since 2010. Prior to that position, she served several other roles within DOJ, including acting inspector general and counselor to the inspector general. Schnedar also previously worked for more than a decade at the US Attorney's Office in DC, where she worked in the Sex Offense and Domestic Violence Section.

In an email to staff, CDER Director Janet Woodcock said she believed Schnedar would be "an asset to CDER and Office of Compliance leadership."

"Her expertise in law enforcement, and extensive experience as an attorney and leader in the federal government, enables her to bring a valuable mix of knowledge and ability to analyze complex statutory and regulatory issues."

Schnedar will step in for Carol Bennett, who has been serving as acting director of the Office of Compliance since Sklamberg's promotion. Bennett will return to the Office of Regulatory Policy, Woodcock said, and OC Deputy Director Ilisa Bernstein will serve as acting director until Schnedar is formally brought on board.