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FDACounsel.com -- Speeches & Articles
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Key Abbreviations
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This part of FDACounsel.com is designed as a resource for you on the wide variety of FDA legal topics and issues
that we have spoken or written about during the past few years. To locate information on a topic of interest, click
on one of the TOPICS under Archives in the lower part of this webpage and you will be taken to a list of
downloadable presentations and articles on that Topic. To view/download an article or presentation, just click on
its title!
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Upcoming Presentations
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FDACounsel.com
In-House Training
Seminars
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Financial and Legal Implications of Risk Management: The Broader Picture. Developing a Risk
Management Strategy: A Hands-On Workshop. Pharmaceutical Education & Research Institute
(PERI), November 10-11, 2004, Washington, D.C.
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Recent Presentations and Articles
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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.
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Study Contracts: Do You Understand What You Just Signed?. North Texas Chapter,
ACRP, Annual Education Symposium, October 16, 2004, Dallas, Texas.
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How to Negotiate Other Important Contract Terms. 14th International Contracting & Negotiating
Clinical Trials. Strategic Research Institute. September 27-28, 2004, La Jolla, CA.
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Case Study: The Generic Drug Scandal. Ethics in Regulatory Affairs, OCRA, August 30, 2004, Irvine, CA.
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Overview of Regulation of Generic Drugs, OTCs, Orphan Products and Cosmetics. SDRAN,
August 18, 2004, San Diego.
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FDA Enforcement -- What You Need To Know To Avoid -- Or Respond. Drug Information
Association Annual Meeting, Half-Day Tutorial, June 2004, Washington, D.C.
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Archives ...
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FDACounsel.com's Archives contain past presentations and articles organized by subject area. Just click on the
Topic Heading below that matches the subject that interests you and you can obtain full text copies, on-line, of
past presentations and articles on key FDA regulatory law issues.
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TOPICS
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Advertising & Promotion
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Generic Drugs
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Import/Export & International Issues
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Clinical Research
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Drug, Biologic & Device Development
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Medical Devices & IVDs
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Dietary Supplements & Functional Foods
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OTC Drugs & Cosmetics
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Outsourcing & Contracting Issues
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FDA Enforcement & Compliance
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Product LifeCycle -- Strategy & Tactics
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© 2004 Law Offices of Michael A. Swit.
ALL RIGHTS RESERVED.
Questions?
Contact us @ 760-815-4762
or
mswit@fdacounsel.com
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