The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.

As FDA prepares to review several popular peptide-related substances, a new public-web audit across 25 states identifies a ...

The top observations identified in Form 483 reports from inspections conducted under the recently implemented Quality Management System Regulation (QMSR) include risk management, outsourcing and ...

FDA Commissioner Marty Makary, MD, has resigned from his role, President Donald Trump confirmed in a May 12 Truth Social post. Eight things to know: 1. The post included a screenshot of a text message ...

Marty Makary, the Johns Hopkins surgeon who has led the FDA for the past year, is facing criticism from all sides. Vaping advocates are angry because of the FDA’s slow progress on green-lighting their ...

Jordan Elder has served as the Director of Regulatory Affairs at RCA (A Nelson Labs Company) for the last 15 years, providing clients with general direction, tactical objectives, and functional plans ...

Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tavneos from the market, the California drugmaker denied the request. Now, the U.S. regulator is applying more pressure. The ...

FDA officials (L-R) Laureen Genius, Christina Bigham, Katelyn Staub-Zamperini, and Jeffrey Wooley discussed inspections under QMSR at the MedCon conference in Columbus, OH (credit: Jeff Craven).

Insurers are putting a growing focus on specialty drugs covered under the medical benefit, and on re-evaluating the efficacy of traditional rebate models, according to a new report. The Pharmaceutical ...

Over 1,300 Microsoft SharePoint servers exposed online remain unpatched against a spoofing vulnerability that was exploited as a zero-day and is still being abused in ongoing attacks. The security ...