Food & Drug Bulletin

Dear Reader:

I recently had the opportunity to travel to Russia and the Ukraine to educate their nationals about the regulation of medical devices and pharmaceuticals in the United States. The trip was organized by the U.S. Department of Commerce and included an extensive training program for government officials and private enterprise personnel in the Ukraine and Russia.

On April 3-4 in Kiev, Ukraine and on April 6-7 in St. Petersburg, Russia, I lectured on the fundamentals of device and drug regulation in the U.S. and the European Union (E.U.). Other lecturers included representatives from FDA and Commerce, as well as consultants in device and drug law from the U.S. and E.U. Nearly 200 participants in the Ukraine and 100 in Russia learned about the regulatory structures in Western countries and efforts to harmonize the application of laws to assure prompt availability of safe and effective devices and drugs. The lecture series followed an earlier effort in Kazakhstan when McKenna attorneys assisted this former member of the Soviet Union in developing a regulatory program based on the U.S. model.

The Ukraine/Russia training program represented a significant step in the process of these countries becoming part of the medical regulatory global community. McKenna & Cuneo, L.L.P. is pleased that attorneys from our law firm were invited to participate and that our contribution will enhance beneficial international commerce.

Larry R. Pilot

Chair, Food & Drug Department

Articles In This Issue

FDA AND FTC CRACK DOWN ON UNLAWFUL DISTRIBUTION OF PRODUCT INFORMATION ON THE INTERNET

FDA ISSUES DRAFT GUIDANCES ON CLINICAL TRIALS DATA BANK AND EMERGENCY CLINICAL RESEARCH

FDA ISSUES GUIDANCE ON MEDICAL DEVICE STANDARDS FOR 510(k)S

FDA ISSUES A NOTICE ON THE DECISION IN THE WASHINGTON LEGAL FOUNDATION V. HENNEY CASE

CFSAN SETS PROGRAM PRIORITIES FOR YEAR 2000

MARKING OF PRODUCTS SOLD IN THE EU

COURT DECISIONS FURTHER DEFINE THE RIGHTS OF GENERIC DRUG MAKERS

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