Drugs

Experts Dismiss FDA Drug Development Tools Program

Researchers from Genentech find that FDA’s Drug Development Tools (DDTs) Qualification program has had a very “limited” impact on development programs. Writing in an online post on physiciansweekly.com, the researchers note that the DDT pathway for evaluating clinical outcome assessments (COAs) gets bogged down and takes longer for FDA reviews than projected.

“To date," their post says, "seven COAs (8.1%) have achieved qualification, and one (1.1%) has been denied after undergoing all steps for qualification. On average, it takes six years for a COA to be qualified. Our analysis of FDA’s approval documents shows that the agency has relied on qualified COAs to support benefit-risk assessment of 11 medicines. Only three of the seven qualified COAs have been used to support benefit-risk assessment of medicines.”

The experts suggest that to improve the utility of this program, “FDA should publicly share the timelines so participants can be better prepared to integrate into their development programs. Furthermore, FDA should clearly articulate how and when COAs can be used in drug development.”

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