FDA Policy/General

Panel to Discuss Non-Rx Naloxone Spray

Federal Register notice: FDA is announcing a 3/20 joint meeting of its Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees. Panel members are scheduled to discuss a Harm Reduction Therapeutics NDA for naloxone hydrochloride nasal spray, 3 mg/0.1 mL, for proposed nonprescription use as an opioid reversal agent in opioid overdose emergency treatment. The agency notes that the product represents a potential first-in-class product in a new therapeutic category for nonprescription drugs. Meanwhile, the joint panels are also meeting 2/15 (see earlier notice) to discuss an Emergent BioSolutions supplemental NDA for Narcan (naloxone HCl) nasal spray, 4 mg/.1 mL, which is proposed for nonprescription treatment of known or suspected opioid overdose. To view the new 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