Drugs

CGMP Violations Seen in Eurofins Labs Inspection

A 6/1-6/3 FDA inspection at the Eurofins SF Analytical Laboratories drug manufacturing facility in Horsham, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 10/6 Warning Letter says the three specific violations were:

failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet its specifications, whether or not the batch had been already distributed; and
failure of the firm’s quality unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The agency recommends that Eurofins engage a qualified consultant to perform a comprehensive six-system audit of its entire operation, assist it in meeting CGMPs, and evaluate the completion and efficacy of its corrective and preventive actions before it pursues resolution of its compliance status with FDA.

Some Advisory Committee Patient Reps Have Conflicts: Study

An analysis by two University of Southern California policy researchers finds that between 2013 and 2022, some 38% of FDA advisory committees included either a patient or consumer representative with active ties to an advocacy organization funded by a drug company. Writing in an open-source article for Project Hope,

Former FDA Official Questions Agency Role in Drug Pricing

Former FDA regulatory counsel and now-partner at Spencer Fane Brian Malkin is questioning whether the agency should become more directly involved in the Trump administration's drug-pricing initiatives, raising concerns about the potential direction of FDA policy under commissioner nominee Heidi Overton, whose nomination remains pending in

FDA Uses Machine Learning to Identify Opioid CV Signals

FDA researchers and academic collaborators identified nearly 80,000 prescription opioid-related cardiovascular adverse event signals in a large-scale analysis of the agency's Adverse Event Reporting System, suggesting that machine learning could improve postmarketing drug safety surveillance. The study, published September 28 in Frontiers in Drug Safety

FDA Will Review Formycon’s Keytruda Biosimilar

FDA has accepted for review a Formycon/Zydus Lifesciences BLA for FYB206, a biosimilar to Merck’s blockbuster cancer drug Keytruda (pembrolizumab). A statement says the biosimilar was developed without a comparative Phase 3 efficacy trial, following a development pathway agreed upon with FDA in early 2025. The companies say

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Some Advisory Committee Patient Reps Have Conflicts: Study

Former FDA Official Questions Agency Role in Drug Pricing

FDA Uses Machine Learning to Identify Opioid CV Signals

FDA Will Review Formycon’s Keytruda Biosimilar