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CLE: The FDA Amendments Act: Overview and Implications for Pharmaceutical Manufacturers

October 22, 2007
AstraZeneca Pharmaceuticals
Fairfax Office Complex/Research Center 1800 Concord Pike
Wilmington, DE
19850-5437
By Daniel A. Kracov

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.

To RSVP for this event, please send an email to events@aporter.com.

*Arnold & Porter is an accredited CLE provider in NY and CA. CLE Credit in all other jurisdictions is pending and is not guaranteed.

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Daniel A. Kracov
Daniel A. Kracov
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