FDA Policy/General

Regulatory Science Centers Growing

FDA Office of Chief Scientist critical path and regulatory science initiatives director Frank Weichold says that since 2012, the agency’s Centers for Regulatory Science and Innovation (CERSI) have grown from two to four Centers involving five universities and one nonprofit hospital. As of 12/2018, he says, the program has resulted in over 90 research projects and 132 publications.

Writing in Clinical Pharmacology and Therapeutics, Weichold says that having multiple CERSIs allows the program to build on the strengths and expertise of each CERSI and their proximity to industrial life science hubs. “This allows us to take advantage of the world’s best scientists, and through these collaborations FDA scientists can provide greater leadership and guidance to academia, industry, and patient groups.”

The four current CERSIs are supported by cooperative agreement grants from FDA, Weichold says. “Lacking a congressional mandate,” he explains, “these grants are dependent on relatively limited stagnant funding from the FDA chief scientist’s budget, and individual projects mostly get funding from the FDA Centers, subject to availability of resources during a given fiscal year budget cycle. The CERSI subcommittee on the FDA Science Board made strong recommendations to increase the funding in its 2016 report.”

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