FDAAA Enforcement Summary Now Available

February 6, 2008

The latest FDLI Update article by Hyman, Phelps & McNamara, P.C.’s Gwen M. McKee and John R. Fleder discusses the enforcement provisions of the Food and Drug Administration Amendments Act of 2007 (“FDAAA”).  While the enforcement provisions of FDAAA have frequently been ignored in public discussions about the new law, they are important for anyone working in the area to be aware of – particularly those entities affected by the new clinical trial database requirements, risk evaluation and mitigation strategies, or direct-to-consumer advertisements.

Those interested in a broader discussion of the new law can still access the previous, comprehensive analysis issued by Hyman, Phelps & McNamara, P.C.

Categories: Enforcement