Drugs

Industry, FDA Agree on New Generic User Fees

FDA and the generic drug manufacturing industry have reached agreement on an extension of the Generic Drug User Fee Amendments of 2012 (GDUFA), which expire in 2017. GDUFA 2 will run from FY 2017 through FY 2022. Generic Pharmaceuticals Association (GPhA) vice president for scientific and regulatory affairs David Gaugh says that the commitments outlined for GDUFA 2 “enable FDA to continue delivering on its promise to protect public health by ensuring access to safe and effective generic medicines.”

GPhA says that key GDUFA 2 provisions include: GDUFA backlog ANDA provisions, priority and standard review, enhanced communication and transparency, complex product meetings, enhancements to the inactive ingredient database, resource management and planning and performance reporting, and small business relief.

The association says it is optimistic that the agreement’s provisions will streamline approvals by assigning goal dates to all ANDAs to assure that no GDUFA 1 submissions are left behind. It also will provide the agency with additional resources, improving transparency and accountability to enhance its ability to meet GDUFA 2 goals, GPhA says.

“Process changes and staff additions have been positive steps thus far,” the advocacy group says, “and the addition of enhanced performance reporting sets an even stronger foundation for translating FDA actions on generic applications to approvals.”

The agreement was hailed by the Pharma & Biopharma Outsourcing Association, which says that “industry, FDA, and patients will see great benefits from the program during the next five-year period.”

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