FDA Policy/General

FDA Preliminary Assessment on OTC Naloxone

Federal Register notice: FDA has announced its preliminary assessment that certain types of naloxone hydrochloride drug products may be approvable as safe and effective for nonprescription use to counteract opiod overdose. It found that naloxone nasal spray up to 4 milligrams (mg), and naloxone autoinjector for intramuscular or subcutaneous use up to 2 mg, have the potential to be safe and effective for use as directed in nonprescription drug labeling. It noted, however, that additional data is needed, such as product-specific data on the nonprescription user interface design, including packaging and labeling, to make a conclusive determination. Therefore, if and when FDA has sufficient data to support approval of a nonprescription naloxone product (e.g., through submission and approval of an application for a nonprescription naloxone product or a supplemental application to switch an FDA-approved naloxone product from prescription to nonprescription status), currently marketed naloxone products labeled as ‘‘Rx only’’ with no clinically meaningful difference from the approved nonprescription products would be considered misbranded. To view the notice, click here.

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