Drugs

FDA Wants Generic Drugs Harmonized Globally

FDA commissioner Scott Gottlieb says a new step in the agency’s effort to reduce drug costs by promoting competition is a request to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use to pursue common global development standards for generic drugs. Writing in an FDA Voices blog post, Gottlieb says generic drug developers “should be able to implement a single global drug development program and utilize common elements of applications to file for approval in multiple markets. This would make it easier for developers that would otherwise only seek generic drug approval in one region to also seek approval in the United States, increasing competition in America. And it would also make it easier for developers that would otherwise only seek generic drug approval in the U.S. market to gain access to other markets.”

The post says the ultimate goal of the global harmonization of scientific and technical requirements would be the attainment of a single global generic drug development program that can support simultaneous regulatory filings across multiple markets. “Harmonization of these requirements is foundational to achieving a future goal of enabling global approval for high quality generic drugs,” Gottlieb writes.

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