Angie Drakulich

The FDA Center for Drug Evaluation and Research's Office of Compliance is undergoing some major structural reorganization, according to an internal letter to the CDER staff from Director Janet Wookcock, dated May 26, 2011, which was shared with Pharmaceutical Technology by the agency press office. Specifically, the Office of Compliance will be elevated to a "Super Office." Similar offices exist within CDER including the Office of Pharmaceutical Science. The change means that the Office of Compliance will house subordinate offices, including four new offices, three of which are similar to existing divisions, according to the letter. The new fourth office will be called the Office of Drug Security, Integrity & Recalls (ODSIR) and will focus on addressing the challenges of globalization and an increasingly complex drug supply chain. This includes dealing with supply-chain security, counterfeit and diverted drugs, economically motivated adulteration, import operations, and drug recalls, according to the announcement.

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, according to a new report from the Tufts Center for the Study of Drug Development, based in Boston. There are, however, substantial challenges ahead for biopharmaceutical manufacturers if they wish to maintain that pace, said Janice Reichert, PhD, research assistant professor at Tufts University and author of the study, in a press release about the report.

FDA is collecting public comments on a series of studies that the agency plans to conduct on online direct-to-consumer (DTC) promotion of prescription drug products, according to an announcement in the Apr. 28, 2011, Federal Register.

The US Food and Drug Administration posted on its website the minutes of the latest meetings between the agency and industry, and among stakeholders, regarding the reauthorization of the Prescription Drug User Fee Act V. The meetings were held Nov 17-18.