Regulatory Roundup: FDA Publishes CDER Presentation, and more.

Jan 13, 2011
By PharmTech Editors

FDA has published on its website a presentation given by Center for Drug Evaluation and Research (CDER) Director Janet Woodcock on Dec. 9. 2010. The presentation provides a thorough overview of CDER efforts, including the Sentinel initiative, new molecular entity approvals, REMS, and more.

FDA issued on Jan. 7, 2011 another warning about criminals posing as agency officials and other law enforcement personnel as part of a continued international extortion scam. In most cases, criminals call victims who have purchased drugs over the Internet and say they are being charged a fine of $100 to $250,000. Victims are asked to wire the money, and if they do not do so, are often threatened. See the agency’s list of questions and answers about the scam.

The agency has announced a CDER Forum for International Drug Regulatory Authorities to take place April 4–8, 2011, in College Park, MD. The annual forums provide an overview of CDER offices. The 2011 forum will also focus on a product review case study of Etravirine, which is used to treat HIV, to demonstrate how CDER product reviews work. Registration information and requests should be sent to CDERForum@fda.hhs.gov.