Inside the FDA Approval Process

Hanover Office, Palo Alto
May 19, 2010
Join us along with two of the FDA's top legal advisors from the previous administration for an interactive breakfast conversation that provides a look inside the FDA.

The regulatory pathway for a new device is one of the biggest hurdles facing companies today and you must be well positioned to win approval from the FDA. How will recently announced changes to the FDA's scientific review process for 510(k) applications affect approval timing for medical devices and drug/device combinations?

Please join us for an in depth look at the ever-changing FDA approval landscape and a chance to ask your most vexatious questions about winning approval for your device.

Wednesday, May 19, 2010
7:30 – 8:00 a.m. – Networking Breakfast
8:00 – 9:30 a.m. – Presentation and Discussion

7:30 – 8:00 a.m. – Networking Breakfast8:00 – 9:30 a.m. – Presentation and Discussion
Silicon Valley Bank
2400 Hanover Street
Palo Alto, CA

RSVP by May 14, to James Taylor at 415.764.3122 or

About the Speakers:
Scott D. Danzis, Partner, Covington & Burling LLP Scott Danzis is a partner in the firm's Food & Drug and Health Care practice groups. From 2006 to 2008, Mr. Danzis served as the Special Assistant to the Chief Counsel of the FDA. Scott also recently authored a book on the regulation of in vitro diagnostic products.

Gerald F. Masoudi, Partner, Covington & Burling LLP Gerald Masoudi is a partner in the firm's Washington, DC office and co-chair of the Food and Drug practice group. Mr. Masoudi most recently served as Chief Counsel of the FDA.

About Covington & Burling LLP: Covington & Burling LLP, is an international law firm with an unparalleled ability to provide strategic advice and representation to life sciences companies.
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