Following an FDA inspection of its North Carolina facility that found inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva on employee clothing, Shanghai-based CARsgen Therapeutics has…
House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) has requested that the CEOs of three major pharmacy benefit managers (PBM) correct the record for statements made last month…
This edition of Quick Notes provides approval notes on treatments for hypoparathyroidism, prurigo nodularis, primary biliary cholangitis and graft-versus-host disease. Source: Drug Industry Daily
Sponsors appear more informed and prepared than sites for the upcoming changes to the ICH E6 — Good Clinical Practices guideline, according to a newly published survey by Avoca, a…
The FDA has finalized guidance on the Voluntary Malfunction Summary Reporting (VMSR) program that allows manufacturers to submit medical device reports (MDRs) for certain low-risk devices to the agency on…
The CEO that founded Liveyon, a manufacturer and distributor of stem cell-derived products tied to bacterial infections requiring hospitalization, has plead guilty to felony distribution of unapproved drug products, the…
In this edition of Quick Notes EU, we note a new EMA guidance on treating exposure to chemical agents used as weapons, the UK’s decision to offer Vertex’s gene editing…
This excerpt is from the management report titled “Using Real-World Evidence in Drug and Device Submissions,” based on a webinar from FDAnews, A WCG Company. The presenters were Kristin Zielinski…
Failure to conduct complete testing on sterile injectables, falsified monitoring records of areas used for aseptic filling lines as well as falsified cleaning records are among the serious lapses documented…
Regeneron Pharmaceuticals has confirmed that the FDA will not make a decision on approving its investigational multiple myeloma drug linvoseltamab for at least the next few months, citing problems encountered…