FDA Given New Enforcement Authority Under FDAAAFebruary 5, 2008 Download PDF
The latest FDLI Update article by Hyman, Phelps & McNamara, P.C., discusses the enforcement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA). While the enforcement provisions of the new law have frequently been ignored in public discussions about the 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.
- John R. Fleder