Drugs

FDA Wants iPLEDGE Web Site Solutions

FDA is asking the Isotretinoin Products Manufacturers Group (IPMG) to consider a potential temporary solution to help resolve issues patients, prescribers, and pharmacies are experiencing with the implementation of the modified iPLEDGE risk evaluation and mitigation strategy (REMS). An agency document says issues include an inability to log in to the Web site or long call center wait times, resulting in disrupted access to treatment for many patients.

A REMS is needed, FDA says, because isotretinoin carries a high risk of fetal injury, severe birth defects, and pregnancy loss if taken by people who are pregnant.

The notice says FDA is prepared to exercise regulatory flexibility temporarily as needed for certain requirements of the iPLEDGE REMS provided the IPMG proposes a workable solution that also ensures necessary safe use conditions are maintained.

The agency says it has strongly encouraged the IPMG to work with the American Academy of Dermatology and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition to the modified iPLEDGE program.

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