Drugs

FDA Issues GAIN Report

As required under the 2012 FDA Safety and Innovation Act, FDA has submitted to Congress its report on the Governing Antibiotic Incentives Now (GAIN) law addressing the public health threat of antibacterial drug resistance by stimulating the development and approval of new antibacterial and antifungal drugs. The document describes these activities and accomplishments:

designation and review of qualified infectious disease products under GAIN;
review and revision of guidance documents;
engagement to support the development of antibacterial drugs; and
development and implementation of stewardship programs.

“Despite these accomplishments, significant scientific and economic challenges remain because of the nature of serious acute bacterial infections,” the report says. “We continue to explore whether there are potential changes to GAIN that could better focus the program to promote the development of novel antibacterial and antifungal drugs. Efforts beyond GAIN are needed to build an antibacterial research and development enterprise capable of bringing new drugs to the patients who need them.”

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