Drugs

ANDA Label Update Guidance

FDA has issued a draft guidance, Updating ANDA Labeling After the Marketing Application for the Reference-Listed Drug Has Been Withdrawn, to describe a process for updating labeling for ANDAs in cases when FDA has withdrawn approval of the NDA for the reference-listed drug (RLD) for reasons other than safety or effectiveness. The document says that when approval for the NDA has been withdrawn by the agency under these circumstances, and ANDAs are pending or generic drugs continue to be marketed under one or more ANDAs that rely on the withdrawn RLD, the labeling of the pending or marketed ANDA products “may need to be updated to reflect changes that would have been necessary had the NDA for the RLD not been withdrawn.”

The guidance lays out ways in which FDA may seek to facilitate labeling revision to reflect updated information for ANDAs that rely on withdrawn NDAs. “We anticipate that this guidance will help facilitate labeling updates for approved ANDAs as well as the approval of certain pending ANDAs where the NDA for the RLD has been withdrawn,” it says.

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