Brassica Pharma, a maker of sterile semi-solids, received an FDA Warning Letter for failure to test every batch for sterility as well as fabrication of test results for batches not…
Despite another attempt by Ipsen Biopharmaceuticals to regain market exclusivity for its injectable neuroendocrine tumor drug Somatuline Depot (lanreotide), an appeals court has ruled once more in favor of the…
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 Draft guidance was issued on pediatric inflammatory bowel disease and postapproval manufacturing…
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…
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…
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…
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…
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…
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 —…