PharmExec Blog

CDER Addresses 'Challenges of Globalization' With a New Office

CDER's Super OfficeIn recognition of the difficulties presented by a rapidly expanding global drug market, FDA’s Center for Drug Evaluation and Research (CDER) has created a new office “dedicated to addressing the challenges of globalization and an increasingly complex drug supply chain,” according to memo sent by CDER director Janet Woodcock.

The new “Office of Drug Security, Integrity & Recalls (ODSIR)” will “take the lead in dealing with issues such as supply chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls,” Woodcock wrote in the memo. Organizationally, the ODSIR division will be housed along with three other divisions under the Office of Compliance. As a result, the Office of Compliance will be turned into a “Super Office,” meaning it houses subordinate offices.

Woodcock tapped Deb Autor, director of the compliance office, to lead the super office. Autor is behind FDA’s efforts – beginning in 2006 – to eradicate unapproved products from the market.

“The drug industry we regulate has become a global enterprise, and our mission of ensuring the safety, quality, and integrity of drugs for the American people has become an increasingly complex challenge,” Woodcock wrote in the memo.

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