Drugs

Tropical Disease Voucher Guidance Out

FDA has issued a guidance, Tropical Disease Priority Review Vouchers, discussing implementation of part of the FDA Amendments Act of 2007 that authorized the agency to award priority review vouchers to sponsors of certain tropical disease product applications that meet specified criteria. The agency says it has received numerous inquiries about the scope of the law and how various aspects of it should be interpreted.

The guidance notes that the section in question was designed to encourage development of new drug and biological products for preventing and treating certain tropical diseases affecting millions of people throughout the world. Sponsors of qualifying applications for a tropical disease drug may be eligible for a voucher than can be used to obtain a priority review for a subsequent drug application after the date of approval of the tropical drug disease product.

The document includes an overview of the law’s provisions and then questions and answers on policies and procedures involving general information, eligibility, transferability, voucher fees and use, and relationship of the priority review voucher program with other programs.

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