Drugs

Groups Want Old Mifeprex Labeling Restored

The American Association of Pro-Life Obstetricians and Gynecologists and the American College of Pediatricians are petitioning FDA to restore and strengthen elements of the Mifeprex (mifeprostol) regimen and prescriber requirements approved in 2000 and retain the Mifeprex REMS limiting dispensing of the drug to patients in clinics, medical offices, and hospitals by or under the supervision of a certified prescriber. A 3/29 petition says that in 2016 FDA increased the maximum gestational age for Mifeprex use for abortion from 49 days to 70 days, and changed the method of administration from oral to buccal.

“However,” the petition says, “drug-induced abortion regimens demonstrate an increase in complications and failures after 49 days’ gestation.” The petition also challenges other changes made in the labeling, including substituting “healthcare provider” for “physician” and no longer including language requiring access to appropriate medical care should an emergency arise.

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