Drugs

Oncology Drug Cross Labeling Guidance

FDA has published a guidance, Cross Labeling Oncology Drugs in Combination Regimen, with the agency’s current recommendations about including relevant information in the labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of the drugs. The document says a combination regimen refers to two or more drugs that are marketed separately, where at least one of the drugs has an approved indication for the combination based on one or more adequate and well-controlled clinical trials. Cross-labeling is defined in the guidance as the inclusion of information in the approved labeling of two or more oncology drug products approved in a combination regimen for a specific indication.

The guidance does not address all issues that might arise relating to labeling for oncology drugs for use in a combination regimen, the guidance says. It also does not address circumstances in which a drug product and a biological product packaged separately constitute a cross-labeled combination product.

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