FDA Watch
Colleen Heisey, J.D., MPH, Hunton & Williams LLP
April 3, 2013
FDA updates guidance on financial disclosures by clinical investigators
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Colleen Heisey, J.D., MPH, Hunton & Williams LLP
March 6, 2013
Enrichment strategies for clinical trials supporting product approval
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Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP
January 22, 2013
FDA revises draft guidance document to address industry comments
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Colleen Heisey, J.D., M.P.H. and Sharon M. Bradley, J.D., Hunton & Williams LLP
November 9, 2012
Self-identification under the Generic Drug User Fee Amendments
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Adele M. Kaplan Gilpin, J.D., Ph.D. and John G. Moore, J.D., Ph.D., Hunton & Williams LLP
September 6, 2012
Once it’s alleged, what happens next?
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D. Kyle Sampson, J.D., and Brian J. Wesoloski, J.D., Hunton & Williams LLP
July 18, 2012
Court Limits FDA’s authority to regulate pharmacy compounding
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Gary C. Messplay, J.D., Allison L. Reschovsky, J.D., and Adele M. Kaplan Gilpin, J.D., Ph.D., Hunton & Williams LLP
May 30, 2012
A new era of clinical trial transparency enforcement
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Colleen Heisey, J.D., M.P.H. and Sharon M. Bradley, J.D., Hunton & Williams LLP
May 4, 2012
FDA releases guidance on direct-to-consumer TV advertisements
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Heather Banuelos
April 4, 2012
FDA provides draft guidance on biosimilar product development
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Kyle Sampson, J.D., and Brian J. Wesoloski, J.D., Hunton & Williams LLP
March 7, 2012
New guidance seeks to clear up manufacturer communications
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John G. Moore, J.D., Ph.D. and Adele M. Kaplan Gilpin, J.D., Ph.D.
November 14, 2011
Controversial draft guidance challenges precedent and may favor drug jurisdiction
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D. Kyle Sampson, J.D., and Brian J. Wesoloski, J.D.
October 11, 2011
FDA’s proposal to abolish drug pedigree requirements
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Colleen Heisey, J.D.
September 7, 2011
OIG uses its guidelines to target Forest president
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