Posts by PacConAdmin

This week, the FDA published final guidance on glass vials and stoppers, OTC monograph submissions and real-world data. Draft guidance was issued on pediatric inflammatory bowel disease and postapproval manufacturing changes to biosimilars. The agency also announced that it is seeking information and comments on biosimilar product development and host cell proteins. Source: Drug Industry…

FDA issued a Warning Letter to Criticare Technologies for failure to investigate complaints that its nGenuity patient vital signs monitor — which can be used during surgery — had shut off intermittently. Source: Drug Industry Daily

A federal grand jury in Houston has indicted an Indian national with selling and shipping tens of thousands of dollars’ worth of counterfeit oncology pharmaceuticals into the US. Source: Drug Industry Daily

A supplemental BLA for AstraZeneca’s blockbuster cancer drug Imfinzi (durvalumab) for treatment of nonsmall-cell lung cancer (NSCLC) hit a potential speed bump Thursday in a review by the FDA’s oncology advisory panel of the supporting clinical trial. Source: Drug Industry Daily

Jeff Shuren, currently Director of CDRH, has announced that he is leaving the agency after 28 years of service including 15 years as the director. Source: Drug Industry Daily

In this edition of Quick Notes, we cover a workshop on psychedelics, regulations on substances of human origin, selection of the COVID-19 strain for the next vaccines and a 483 for Swiss company Lonza. Source: Drug Industry Daily

Guardant Health has agreed to pay $900,000 to settle allegations that it participated in a scheme with a physician to submit charges to Medicare in violation of the False Claims Act. Source: Drug Industry Daily

Members of the House Committee on Oversight and Accountability grilled the leaders of the nation’s three largest pharmacy benefit managers (PBM) — CVS Caremark, Express Scripts and Optum Rx — in a hearing Tuesday over alleged anticompetitive practices and their companies’ role in increasing prescription drug costs. Source: Drug Industry Daily

The FDA has finalized its guidance on the use of electronic health records (EHR) or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety. Source: Drug Industry Daily

In its efforts to develop new guidances, the FDA is seeking information and comments on evaluating and mitigating the immunogenicity risk of host cell proteins (HCP) and the best way to advance development of new biosimilar biological products. Source: Drug Industry Daily