Drugs

FDA Issues 2 Anti-infective Drug Guidances

FDA has issued two draft guidances to assist sponsors in developing specific types of anti-infective drugs. The first guidance, Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention, addresses the agency’s current thinking about the overall development program and clinical trial designs to support development of drug products with an antiviral mechanism of action used to prevent and/or treat recurrent herpes labialis, caused by either herpes simplex virus type 1 or 2 in immunocompetent subjects. FDA says the document is intended to be a focus for continued discussions among the CDER Division of Antiviral Products, drug sponsors, the academic community, and the public. It does not address development of drug products used to treat systemic, genital, or disseminated herpes virus infections, or herpes labialis in immunosuppressed subjects. It also does not contain discussions of the general issues of statistical analysis or clinical trial design.

The second guidance, Vulvovaginal Candidiasis: Developing Drugs for Treatment, is to assist drug sponsors in the overall clinical development program and clinical trial designs to support drugs for treating vulvovaginal candidiasis. It also is to be a focus for continued discussions among several stakeholders. The document generally focuses only on developing antifungal drugs for treating uncomplicated vulvovaginal candidiasis, generally defined as a single episode of vaginal inflammation caused by Candida yeast in an otherwise healthy female. It does not address complicated vulvovaginal candidiasis; sponsors are encouraged to talk with the agency about a clinical development program for treating complicated vulvovaginal candidiasis (three or more episodes in one year). The guidance does not discuss trial designs for development programs for nonprescription treatments, and also does not discuss general issues in drug development or general issues of statistical analysis or clinical trial design.

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