FDA Policy/General

Safety Alert on Regener-Eyes Eye Drops

An FDA safety alert is warning about Regener-Eyes manufactured by Regenerative Processing Plant because the drops likely contain amniotic fluid. The agency says it has received two adverse event reports about “shooting pain in the eyes: after using Regener-Eyes, an ophthalmic drug product marketed for dry eye conditions. “Although this product is not labeled to contain amniotic fluid, FDA has reason to believe it does, as explained in its 8/16/2024 Warning Letter to Regenerative Processing Plant, LLC that documented unapproved new drug, misbranding, and adulteration (current good manufacturing practice) violations,” the alert says.

The agency says amniotic fluid eyedrops used to treat diseases and conditions are regulated as drugs and biological products and are subject to premarket review and approval requirements. “There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate or cure eye diseases or conditions, and in order for a health care professional to offer these products to patients, there must be an investigational new drug application (IND) in effect,” the alert says.

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