Drugs

FDA, Defense Dept. Launch Drug Development Program

FDA says it is working with the Department of Defense (DoD) to prioritize efficient development of medical products intended to save the lives of American military personnel. A FDA announcement says the program framework comes through legislation that authorized the Defense Department to request, and FDA to provide, assistance to expedite development and agency review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing the country’s military personnel.

Using the law’s expanded authorities, FDA says, the agency will work closely with the DoD Office of Health Affairs to better understand the military’s needs for deployed personnel, give the highest level of attention to and expedite its review of priority DoD medical products in a manner similar to those in the breakthrough designation program, provide ongoing technical advice to the Office of Health Affairs to aid in the rapid development and manufacturing of medical products for use by the military, and take a closer look at products currently under development to determine opportunities to expedite their availability.

The announcement contains a link to the agency’s initial work plan that it says was developed in close collaboration with DoD.

“Ensuring our nation’s warfighters have safe and effective medical products is a top priority for the agency,” FDA commissioner Scott Gottlieb is quoted as saying in the statement. “By standing up [sic] a collaborative program with DoD, we hope to address DoD’s immediate product priorities and ensure these products are developed and made available in the most expeditious manner possible.”

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

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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