CDER’s Drug Integrity Program Gains Formal Role In Compliance Office Reorg
FDA’s nascent Drug Integrity and Security Program gains an enhanced and more formal role with the reorganization and elevation of the Center for Drug Evaluation and Research’s Office of Compliance to “super-office” status.
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Howard Sklamberg, deputy associate commissioner in FDA’s Office of Regulatory Affairs, will take over as director of the Center for Drug Evaluation and Research’s Compliance Office in January; acting compliance director Ilisa Bernstein will resume her role as deputy director.
More than just a bureaucratic shell game, the promotion of the Office of Generic Drugs to “super office” status signals CDER Director Janet Woodcock’s tightened focus on generic drugs.
The Office of Medical Policy now houses the Office of Prescription Drug Promotion (formerly DDMAC) and the newly created Office of Medical Policy Initiatives.