Drugs

Multiple Violations Cited at ProRx Outsourcing Facility

A 7/15-8/2/2024 FDA inspection at the ProRx outsourcing facility in Exton, PA, found evidence that drug products the company produced failed to meet regulatory conditions necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act. A just-released 12/20/2024 Warning Letter says the investigators also found serious deficiencies in the firm’s practices for producing products intended or expected to be sterile, putting patients at risk.

The letter lists findings under the headings Adulterated Drug Products, Unapproved New Drug Products, and Misbranded Drug Products. FDA acknowledges that ProRx ceased sterile drug production as of 8/7/2024 and notified FDA of an intent to resume sterile drug production on 11/11/2024. “We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation,” it says.

The letter says the company should take prompt action to address violations and should respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome