• cGMP Enforcement, the False Claims Act and Lessons From Omnicare

    April 3, 2014
    Mere evidence of noncompliance may not be enough, when attempting to enforce cGMPs via the False Claims Act

  • New Rules on Medicinal Product Clinical Trials in Europe

    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,…

  • New Compounding Legislation

    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…

  • Mobile Medical Apps

    Kyle Sampson and Allison L. Reschovsky, Hunton & Williams LLP || November 13, 2013
    There's an FDA guidance for that

  • IRBs and INDs

    Heather D. Banuelos, Hunton & Williams LLP || October 9, 2013
    Evaluating IRB responsibilities and determining IND exemptions

  • Withdrawing for Safety

    Kyle Sampson, Hunton & Williams LLP || September 5, 2013
    FDA adopts case-by-case approach for opioid analgesics

  • Contract Manufacturing Agreements

    Kyle Sampson, Hunton & Williams LLP || July 17, 2013
    FDA encourages utilization of robust quality agreements with CMOs

  • Physician Payment Transparency

    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…

  • More Scrutiny for cGMP Violations

    Heather Banuelos, Hunton & Williams LLP || May 6, 2013
    DOJ to pursue enforcement

  • In the Interest of Disclosure

    Colleen Heisey, J.D., MPH, Hunton & Williams LLP || April 3, 2013
    FDA updates guidance on financial disclosures by clinical investigators

  • Trial Design Draft Guidance

    Colleen Heisey, J.D., MPH, Hunton & Williams LLP || March 6, 2013
    Enrichment strategies for clinical trials supporting product approval

  • Electronic Data in Clinical Investigations

    Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP || January 22, 2013
    FDA revises draft guidance document to address industry comments

  • Stay Ahead on GDUFA

    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

  • Clinical Trial Misconduct

    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?

  • Drug Manufacturing or Pharmacy Compounding?

    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