Drugs

Researchers Affirm Mifepristone Safety to FDA

In a letter to FDA organized by the UCLA Law Center on Reproductive Health, Law, and Policy and Advancing New Standards in Reproductive Health at the University of California, San Francisco, more than 260 reproductive health researchers nationwide affirm the 25-year safety record of the medication abortion drug mifepristone and urge the agency to reject junk science and continue to make decisions using transparent, rigorous gold-standard science. The letter makes these points:

decades of voluminous gold standard science support the safety and effectiveness of mifepristone, including through telehealth; and
new research that is not reproducible, is methodologically flawed, or both, does not outweigh the overwhelming body of rigorous evidence on mifepristone’s safety and effectiveness.

The letter was sent to the agency in support of petitions already submitted by the American College of Obstetricians and Gynecologists, the Massachusetts attorney general, and GenBioPro, Inc., urging FDA to protect mifepristone.

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