FDA Public Workshop on Drug/Medical Device Regulatory Requirements (June 20-21)

This post was written by Paul Sheives.

FDA will hold a two-day public workshop entitled “The Future of Medical Products Regulation: Ensuring Safety and Integrity in a Global Market.” The workshop, to be held in Dallas, Texas on June 20-21, 2011, is intended to provide the drug and medical device industry information on the following topics: globalization, imports, and supplier controls; medical product theft and criminal investigations, proposed changes to the 510(k) review process; health fraud; streamlining the FDA enforcement process; the future of medical products regulation; medical devices in Canada; the Freedom of Information act; medical product complaint investigations; writing corrective and preventive actions procedures and documents to reflect compliance initiatives; and top ten FDA–483 objectionable observations. Registration for the workshop closes on May 24, 2011.

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