Drugs

Davis Returning to CDER as Deputy Director

Usona Institute chief medical officer Michael C. Davis is returning to CDER as the Center’s deputy director after being gone two and a half years, according to several media reports. He left the agency 12/2022 after serving almost seven years as a clinical team leader in CDER’s Division of Psychiatry. Davis’s return comes as CDER acting director Jacqueline Corrigan-Curay announced 6/23 her decision to retire next month (see earlier story).

Usona Institute is described as a medical research organization “dedicated to supporting and conducting basic, pre-clinical and clinical research to further the scientific understanding and therapeutic application of consciousness-expanding medicines.” Davis was currently working on developing psychedelic drugs for treating major depressive disorder, according to his LinkedIn bio.

Davis obtained his medical degree from Case Western Reserve University School of Medicine and he has a Ph.D degree in pharmacology from Case Western Reserve University.

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