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Focus on Regulation

Tag Archives: cGMP Violations

Hogan Lovells to Host FDLI cGMP Conference: Top FDA/CDER Compliance Officials Will Speak on a Range of cGMP Issues

The Food and Drug Law Institute (FDLI) will hold its “Understanding cGMPs—What Attorneys Need to Know” conference at the Washington, DC office of Hogan Lovells on July 15, 2014. During the conference, which is specifically tailored for lawyers but appropriate for all drugs and biologics stakeholders, attendees will hear from top FDA/CDER Compliance officials, in-house counsel, Hogan Lovells’ lawyers, and others, on how FDA evaluates company compliance with current good manufacturing practice (cGMP) and responds to noncompliance. The conference will highlight recent cGMP developments and provide updates on FDA authority. It will also expand beyond the United States to consider global issues such as import/exports and international inspections.

Fourth Circuit Holds That cGMP Deficiencies Alone Do Not Constitute A False Claims Act Violation

For several years now current good manufacturing practice (cGMP) violations have been viewed as “the next hot thing” in False Claims Act (FCA) litigation.  The $750 million settlement involving SB Pharmaco (a GlaxoSmithKline subsidiary) and the $500 million settlement involving Ranbaxy USA Inc. (a Ranbaxy Laboratories Limited subsidiary) support this view.  But we’ve always understood