Drugs

FDA Denies Part of Contraceptive Study Group Petition

FDA has denied a request in a 5/9/19 petition submitted by Dr. William Williams of the Contraceptive Study Group asking that a Boxed Warning be added to prescribing information and patient-related materials for all combined hormonal contraceptives (CHC) on an increased risk of breast cancer. The agency response says other requests in the petition will be addressed at a later date.

“We do not agree … that a Boxed Warning regarding breast cancer risk is appropriate for the CHC product class,” the letter says. “However, based on the agency’s review of relevant scientific literature, FDA approved a safety labeling change for CHCs on 4/29 to better reflect the agency’s current assessment of breast cancer risk associated with the use of these products.”

The agency response says that taken as a whole, the weight of the evidence based on the studies cited in the petition does not support the claim that CHC use is associated with a significant risk of breast cancer.

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