Drugs

Orally Inhaled Nicotine Drug Product Nonclinical Testing

FDA has published a guidance, Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products, to give sponsors recommendations on the nonclinical information to support the development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. The document focuses on novel chemicals of the drug product formulation, novel chemicals generated from any chemical of the drug product formulation by the delivery system, and novel impurities from the drug product formulation and delivery system. It does not address nonclinical toxicity studies that may be requested by CDRH to support the use of the delivery system.

FDA says that orally inhaled nicotine-containing drug products developed for smoking cessation and related indications are expected to involve continuous use or chronic intermittent use resulting in six months or more exposure over a lifetime. The recommendations for nonclinical toxicity assessment in the guidance are intended to support the indication of smoking cessation and related chronic indications in an adult population for either prescription or nonprescription use, the guidance 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