FDA Legal Aspects of Drug and Device Development

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Drug and Device Development Presentations

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Successful FDA Meetings. West Coast Drug Development Forum: Challenges
in the Development of Therapeutic Products. DIA, Half-Day Tutorial,
October 25-27, 2004, San Francisco.

FDA Legal and Regulatory Strategies for Start-up Companies. Tech Coast
Angels, BioMedTrak Program, March 2003, La Jolla, CA.

FDA’s “Combination” Product Policy. Scripps Clinic-BIO 5th Annual Drug
Development Conference, February 2003, La Jolla, CA.

Legal Strategies in Sourcing of FDA-Regulated Goods and Services – Seeking a
Win-Win Relationship with Your Contract Manufacturing Organization. IBC
Conference on “Scale-Up: From Bench to Clinic”, August 2002, San Diego.

Legal and Regulatory Strategies in Sourcing of Products, Components and
Services for FDA-Regulated Companies. Biotechnology Industry Organization
(BIO) Annual Conference, June 2001, San Diego, CA.

Drug and Device Development Articles

The “De Novo” 510(k) Process and the Reclassification of Class III Devices.
Edited Transcript of Presentation of Michael A. Swit, Esq., at the November 2001
Breakfast Briefing on Current FDA Issues. San Diego, California.

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