CLE: The FDA Amendments Act: Overview and Implications for Pharmaceutical Manufacturers
Fairfax Office Complex/Research Center 1800 Concord Pike
This program is an overview of the newly enacted FDA Amendments Act (FDAAA), and the implications of its provisions for pharmaceutical manufacturers. Topics covered will include the reauthorization of PDUFA, the creation of a new "risk evaluation and mitigation strategy" framework for postmarket drug safety, the creation of a broader national clinical trial registry and results database, and a range of other new FDA authorities and company obligations under FDAAA.
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*Arnold & Porter is an accredited CLE provider in NY and CA. CLE Credit in all other jurisdictions is pending and is not guaranteed.