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Last Updated Monday, May 25 2015


FDA Watch

April 3, 2014
Mere evidence of noncompliance may not be enough, when attempting to enforce cGMPs via the False Claims Act  Read More »
Genevieve Michaux, Hunton & Williams LLP
March 7, 2014
In April 2014, the European Parliament and European Council will officially adopt a new regulation on clinical trials of medicinal products (the Regulation). The Regulation is expected to take effect in May 2016 and will replace Directive 2001/20/EC,…  Read More »
Sheldon Bradshaw & Sharon Bradley, Hunton & Williams LLP
January 24, 2014
In direct response to the 2012 deadly fungal meningitis outbreak that was linked to unsanitary conditions at a compounding pharmacy, Congress recently passed the Drug Quality and Security Act (DQSA), which, among other things, amended Section 503A of…  Read More »
Kyle Sampson and Allison L. Reschovsky, Hunton & Williams LLP
November 13, 2013
There's an FDA guidance for that  Read More »
Heather D. Banuelos, Hunton & Williams LLP
October 9, 2013
Evaluating IRB responsibilities and determining IND exemptions  Read More »
Kyle Sampson, Hunton & Williams LLP
September 5, 2013
FDA adopts case-by-case approach for opioid analgesics  Read More »
Kyle Sampson, Hunton & Williams LLP
July 17, 2013
FDA encourages utilization of robust quality agreements with CMOs  Read More »
Kyle Sampson, Hunton & Williams LLP
June 5, 2013
Less than one year from now, on March 31, 2014, drug manufacturers will disclose to the government nearly all of the payments they will have made to physicians and teaching hospitals for the five-month period ending on December 31, 2013. These volunt…  Read More »
Heather Banuelos, Hunton & Williams LLP
May 6, 2013
DOJ to pursue enforcement  Read More »
Colleen Heisey, J.D., MPH, Hunton & Williams LLP
April 3, 2013
FDA updates guidance on financial disclosures by clinical investigators   Read More »
Colleen Heisey, J.D., MPH, Hunton & Williams LLP
March 6, 2013
Enrichment strategies for clinical trials supporting product approval  Read More »
Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP
January 22, 2013
FDA revises draft guidance document to address industry comments  Read More »
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  Read More »
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?  Read More »
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  Read More »

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