Drugs

Antibiotic Susceptibility Test Guidance

FDA has published a guidance, Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs, with recommendations on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial and antifungal drugs as established by the 21^st Century Cures Act. Included are the agency’s recommendations on (1) how to make the labeling changes for antimicrobial drugs with NDAs or ANDAs; (2) language to remove from the labeling of such drugs; and (3) labeling language to use for all antimicrobial drugs to reference FDA’s Susceptibility Test Interpretive Criteria Web page.

The guidance says that at least every six months FDA will publish on the Interpretive Criteria Web page a notice that (1) recognizes new or updated susceptibility test interpretive criteria standards or parts of standards; (2) withdraws recognition of susceptibility test interpretive criteria standards or parts of standards; and (3) makes any other necessary updates to the lists published on the Interpretive Criteria Web page. In addition, FDA says it will update the Web page with susceptibility test interpretive criteria upon approval of an NDA for an antimicrobial drug, as appropriate.

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