Drugs

New Generic Drug Development Initiatives

FDA commissioner Scott Gottlieb says the agency wants to build on success it has had in promoting robust generic drug entry with two new initiatives that are part of the 2019 budget request. Writing in an FDA Voice blog post, Gottlieb says the first initiative will create a Knowledge-aided Assessment & Structured Application (KASA) review platform to modernize generic drug review from a text-based to a data-based assessment.

“The KASA will enable a structured review that will make the application review process more efficient, and allow deficiencies to be spotted earlier,” he writes. “This will allow FDA to provide earlier feedback to generic drug makers that will, in turn, help to reduce multiple cycles of application review, one of our key aims and a primary focus of our overall efforts to speed market access to new generic medicines.”

The second initiative is to promote more widespread use of existing generic drugs by looking for ways to keep generic drug labeling up-to-date with the latest benefit and risk information. Gottlieb says the budget request will provide funding to allow FDA to assume more responsibility to bring drug labels up to date. The initiative will be launched initially for oncology products. “Our goal is to help ensure that doctors and patients have up-to-date information for these products,” he says.

The post also reviews how several policies already implemented under the Drug Competition Action Plan are showing benefits in promoting generic drug entry to foster competition and lower drug costs.

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