FDA Policy/General

Galderma Sent Complete Response Letter

FDA has issued Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating moderate-to-severe glabellar lines (frown lines) associated with corrugator or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis oculi muscle activity in adult patients.

The agency letter cites “certain deficiencies isolated to items related to chemistry, manufacturing, and controls processes,” Galderma says. “All other aspects of the BLA, including safety and efficacy related parts, did not solicit deficiencies to be addressed.” The company says it has identified changes to the manufacturing process to address FDA’s concerns, and it will be seeking further guidance from agency reviewers to resolve the issues.

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