Mark’s Memo: FDA Updates and News Briefs | 06/16/10

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Mark Mansour, Partner, Bryan Cave, LLP

FDA: Genetic Testing Kits are Medical Devices

The FDA has sent letters to five manufacturers of genetic testing kits stating that the agency is considering the kits to be medical devices. As such, the agency has said that they need to receive approval from the agency before they can be marketed. The House Energy and Commerce Committee has announced that it too is looking into the tests.

FDA Requests Notifications of Intention to Participate in Meetings on PDUFA Reauthorization

The FDA has issued a notice requesting that public stakeholders notify the agency of their intent to participate in periodic consultation meetings on reauthorization of the Prescription Drug User Fee Act (PDUFA). After the statutory authority for PDUFA expires in September 2012, the FDA will consult stakeholders to develop recommendations for the next PDUFA program. Notifications of intention to participate must be submitted by June 25, 2010. The first stakeholder meeting will be held on July 1, 2010, from 9 a.m. to 11 a.m. More information is available here.

FDA Corrects Dental Device Final Rule

The FDA has issued a notice that it is correcting an error in its Final Rule on dental devices, published on August 4, 2009. More information is available here.

FDA Seeks Comments on Labeling Requirements, Premarket Approval, Drug Co-Development

The FDA is seeking comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products. Comments are due by August 2, 2010. More information is available here.  The FDA is seeking comments on requirements for premarket approval of medical devices. Comments are due by August 9, 2010. More information is available here. The FDA also seeks comments on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to develop guidance for industry and other affected parties on the co-development of two or more novel drugs intended to be used in combination (but not as not fixed-dose combinations) and is seeking public input to identify the affected parties’ information needs concerning such co-development. Comments are due by September 7, 2010. More information is available here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

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