Drugs

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program

FDA has announced a Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee joint meeting 3/28-29/2023 to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for acne drug isotretinoin. An agency notice says the panel will discuss revised REMS requirements to “minimize burden on patients, pharmacies, and prescribers while maintaining safe use of isotretinoin oral capsules for patients.”

A year ago, a new, gender-neutral approach to the isotretinoin risk mitigation program was rolled out and it was met with numerous glitches. On 12/23/2021, FDA issued a notice saying it was aware that patients, prescribers, and pharmacies were experiencing difficulties with implementing the modified iPLEDGE REMS program, including the inability of many participants to log in to the Web site or long call center wait times, resulting in disrupted access to treatment for many isotretinoin patients. ”We understand and share the frustration caused by these challenges and are urging the isotretinoin manufacturers to develop and implement a workable solution as soon as possible,” the agency said.

Details about the meeting topics, including an agenda, have not yet been posted.

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

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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