Drugs

Allergic, Nonallergic Rhinitis Guidances Out

FDA has published guidances to assist sponsors in developing products to treat allergic and nonallergic rhinitis. Allergic Rhinitis: Developing Drug Products for Treatment addresses issues of trial design, effectiveness, and safety for new products being developed to treat seasonal allergic rhinitis and perennial allergic rhinitis. The document says its recommendations are based on an assessment of important issues raised in the review of both adult and pediatric allergic rhinitis clinical trials and FDA’s current understanding of the mechanism of the two related disorders. It does not contain discussion of the general issues of statistical analysis or clinical trial design. The guidance includes an Introduction, Background, Overall Considerations – Adult Program, Overall Considerations – Pediatric Program, Protocol Issues and Elements, Dated Analysis Issues, and Fixed-Dose Combination Products.

The second guidance, Nonallergic Rhinitis: Developing Drug Products for Treatment, discusses issues regarding the definition of a clinical phenotype, trial design, efficacy, and safety for new drug products under development. In particular, it addresses development programs for treating vasomotor rhinitis, a subtype of nonallergic rhinitis. It includes an Introduction, Background, General Considerations for Development, and Considerations for Pediatric Development.

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