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, ...

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 ...

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 ...

Globus Medical, a manufacturer of surgical robots, received an FDA Warning Letter after the company’s inadequate response failed to address findings regarding screws misplaced during surgeries, lack ...

Citing ethical and data concerns, four US lawmakers have begun an investigation into clinical research conducted jointly by American biopharma firms and the Chinese military, as well as trials run in ...

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 ...

In observance of Labor Day holiday, FDAnews will not be published Monday, Sept. 2. The next issue will be published Tuesday, Sept. 3.

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 ...

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 WCG company. The ...

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 ...

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 ...

Pfizer has announced its new digital platform — PfizerForAll — which will partner with a network of healthcare organizations to help patients find and access care, fill prescriptions and find ...