Food & Drug Bulletin

Dear Reader:

From October 17-19, 2000, I was honored to speak at the EUCOMED 2000 General Assembly in Berlin, Germany. EUCOMED, based in Brussels, is a scientifically-based European association of more than 40 multi-national corporations and 25 national and pan-European trade associations that research, develop, manufacture, test, sell and distribute medical devices and related technologies. My presentation to the EUCOMED members raised the issue that FDA's non-U.S. inspection policies appear to discriminate against European firms. An article on this trend is included herein.

Claudio A. Mereu of our Brussels office joined me in lecturing at the EUCOMED conference. Mr. Mereu highlighted various implications of business conducted over the Internet on the European medical device industry, as well as the European Union's regulatory responses to e-commerce, including the European Commission Directive on E-commerce and Digital Signatures.

Although these presentations focused on the interests of the device industry, the same concerns apply to all international manufacturers of FDA-regulated products. World trade and regulatory harmonization issues provide equal challenges to industry, governmental agencies, and the incoming administration of President-elect George W. Bush.

Larry Pilot

Sincerely,

Larry Pilot

Articles In This Issue

Regulators Focus on Clinical Research

FDA Authorizes B-Vitamin Claim with Qualification

FDA Settles Lawsuit on Unapproved Digoxin Tablets

FDA's Detention Policies Discriminate Against Non-U.S. Firms

FDA'S Off-Label Use Notice Does Not Violate Court's Injunction

M&C Files Amicus Brief on Federal Preemption of Device Tort Claim

Click here to access/download the Food & Drug Bulletin (January 2001) in Adobe Acrobat (PDF) format.

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