FDA Policy/General

Ex-FDAer Laughren Joins Cybin Advisory Board

Retired FDA psychiatry products director Thomas Laughren has joined Cybin as a clinical advisory board member. The biotechnology company is focused on progressing psychedelic therapeutics, and it says Laughren is familiar with the potential challenges, and he brings extensive psychiatric regulatory and development expertise to its advisory board.

Laughren retired from FDA in 2012. Prior to joining the agency in 1983, Laughren worked at the Veterans Administration Medical Center in Providence, RI, and was on the faculty of the Brown University Program in Medicine. He began his FDA career as a clinical reviewer in the former Division of Neuropharmacological Drug Products (DNDP). In 1986, he became the team leader for psychiatric drugs. He served there until 2005 when DNDP was separated into neurology and psychiatry divisions.

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