After years of arguing about the legality of distributing medical journal articles concerning unapproved uses for approved drugs and devices, the FDA has finally released a draft guidance recognizing such distribution as a normal activity. The guidance on Good Reprint Practices outlines the type of articles suitable for dissemination to healthcare professionals, the types of articles which should not be disseminated, and acceptable methods of distribution. However, in some ways this new guidance may be even more rigorous than past programs. It could even be argued that some of the provisions are unconstitutional.
In this audio conference, our speaker discusses the scope of the draft guidance on Good Reprint Practices and provide expert advice on implementing a program to ensure compliance for drug and device companies.
Good Reprint Practices: What the FDA Says Now was presented by Robert J. Klepinski, with Fredrikson & Byron and aired on 2008-09-04, and is available at www.fxconferences.com
