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FDA Watch

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Colleen Heisey, J.D.
September 1, 2010
Advertising and promotional activities by drug and device manufacturers are a significant and vigilant focus of the U.S. Food and Drug Administration's (FDA) enforcement activities. Of primary concern to FDA are the scope and manner in which risk inf…  Read More »
Colleen Heisey
July 9, 2010
FDA issues transparency proposals affecting industry  Read More »
Gary C. Messplay, J.D. and Colleen Heisey
June 1, 2010
FDA enlists healthcare professionals in promotional surveillance  Read More »
Gary C. Messplay, J.D.
May 10, 2010
New proposed rule from FDA to ensure data validity  Read More »
Gary C. Messplay and Adele M. Kaplan Gilpin
April 5, 2010
FDA cautiously encourages use of adaptive design clinical trials  Read More »
Gary C. Messplay and Colleen Heisey
March 3, 2010
FDA's new guidance to aid sponsors with CSA  Read More »
Gary C. Messplay and Colleen Heisey
January 22, 2010
A busy year for the agency  Read More »
Gary Messplay and Colleen Heisey
November 6, 2009
New guidance explores PCIDs  Read More »
Gary C. Messplay and Colleen Heisey
October 8, 2009
Facility photographs and FDA inspection authority  Read More »
Gary C. Messplay, J.D.
September 3, 2009
Protecting human subjects and preserving research integrity  Read More »
Gary Messplay and Colleen Heisey
July 15, 2009
States consider extending manufacturer responsibility to product disposal  Read More »
Gary C. Messplay and Colleen Heisey
June 3, 2009
An Overview of the Commonwealth's new Code of Conduct  Read More »
Gary C. Messplay and Colleen Heisey
May 4, 2009
GAO conducts international study on behind-the-counter drugs  Read More »
Gary C. Messplay, J.D.
March 4, 2009
Documents that CMOs need to know  Read More »
Gary C. Messplay and Colleen Heisey
January 22, 2009
New document covers principles and practices guiding process validation  Read More »

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