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FDA Watch

At the Biosimilar Trailhead
Colleen Heisey, J.D.
June 6, 2011
Congress created a path, but where does it lead?   Read More »
Oversight of Clinical Investigators
Colleen Heisey, J.D.
April 29, 2011
Expanding the scope of disqualification  Read More »
Pharmacoepidemiologic Safety Studies
Colleen Heisey, J.D.
April 5, 2011
FDA drafts guidance on best practices  Read More »
Are State Aggregate Spend Laws Here To Stay?
D. Kyle Sampson, J.D.
March 7, 2011
State sunshine laws in a post-federal sunshine law world  Read More »
Food Safety Legislation
John G. Moore
January 24, 2011
Major impact on the dietary supplement industry  Read More »
Reporting Requirements For IND Trials
Colleen Heisey, J.D.
November 10, 2010
FDA sharpens criteria for reporting  Read More »
Draft Guidance Document for Industry
Colleen Heisey, J.D.
October 8, 2010
CMC postapproval manufacturing changes reportable in annual reports  Read More »
Presenting Risk in Drug Advertising
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 »
TMI?
Colleen Heisey
July 9, 2010
FDA issues transparency proposals affecting industry  Read More »
The Bad Ad Program
Gary C. Messplay, J.D. and Colleen Heisey
June 1, 2010
FDA enlists healthcare professionals in promotional surveillance  Read More »
Reporting Falsified Data
Gary C. Messplay, J.D.
May 10, 2010
New proposed rule from FDA to ensure data validity  Read More »
Adaptive Clinical Trials
Gary C. Messplay and Adele M. Kaplan Gilpin
April 5, 2010
FDA cautiously encourages use of adaptive design clinical trials  Read More »
Assessing Drugs with Potential for Abuse
Gary C. Messplay and Colleen Heisey
March 3, 2010
FDA's new guidance to aid sponsors with CSA  Read More »
FDA Enforcement Actions in 2009
Gary C. Messplay and Colleen Heisey
January 22, 2010
A busy year for the agency  Read More »
Combating Counterfeit Drug Products
Gary Messplay and Colleen Heisey
November 6, 2009
New guidance explores PCIDs  Read More »

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