Member Briefing - February 2009

Interview with Gerald Masoudi, Outgoing Chief Counsel of the U.S. Food and Drug Administration
Marc Wilenzick, Esquire, Pfizer Inc., New York, NY
Erika Lietzan, Esquire, Covington & Burling LLP, Washington, DC
Stefanie Doebler, Esquire, Covington & Burling LLP, Washington, DC

The Life Sciences Practice Group is especially pleased to provide you with notes from an interview conducted on January 26th, 2009, by Marc Wilenzick, Erika Lietzan, and Stefanie Doebler with Gerald Masoudi, who recently stepped down from his position as Chief Counsel of FDA.

AHLA invites your responses and perspectives on the key issues facing FDA's next Chief Lawyer, the role of the FDA Chief Counsel's office, or other issues noted in the interview with Mr. Masoudi. Follow-up perspective should be no longer than 1,500 words and sent electronically to the attention of Seth Levy, Publications Vice Chair for the Life Sciences Practice Group. Questions about possible topics can be discussed with Marc Wilenzick and Erika Lietzan, co-chairs of the AHLA Life Sciences Practice Group's Regulatory Law Affinity Group. The responses are being posted below as they are received.

Commentary

Does FDA’s “Changes Being Effected” Final Rule Really Change Anything?
Kimberly K. Egan, Esquire, DLA Piper US LLP, Washington, DC

Issues Facing the FDA and the Next Chief Counsel
Areta Kupchyk, Esquire, Reed Smith LLP, Washington, DC

Regulating a Horse of a Different Color
Rachel Lattimore, Esquire, Arent Fox LLP, Washington, DC
Joanne Hawana, Esquire, Arent Fox LLP, Washington, DC

Comment on Masoudi Interview
Dan Kravoc, Esquire, Arnold & Porter LLP, Washington, DC

FDA Reprint Guidance
Sandra Dennis, Esquire, BIO, Washington, DC