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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 Draft guidance was issued on pediatric inflammatory bowel disease and postapproval manufacturing changes to biosimilars.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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Merck announced that its investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease met its primary safety and efficacy endpoints. Read More
Prescription benefit managers (PBM) use drug rebate payments to promote use of brand name drugs instead of generics, says a report released ahead of a House Committee on Oversight and Accountability hearing on PBMs. Read More