FDA Policy/General

Sherman Named Gottlieb’s Top Deputy

FDA Deputy Commissioner and Office of Medical Products and Tobacco director Rachel Sherman has accepted the position principal deputy commissioner. In this role, Sherman will oversee all medical programs and initiatives that are cross-cutting and clinical, scientific, and/or regulatory in nature, according to FDA commissioner Scott Gottlieb. “She will also provide advice and counsel relating to medical product regulation,” he says. “She will be working closely with me to develop and implement several key agency initiatives as she had done recently by assuming responsibility for the Opioid Policy Steering Committee and initiating the PDUFA hiring pilot.”

Sherman had retired from the agency in 2014 and subsequently joined Greenleaf Health as principal of the firm’s drug and biological drug products consulting business. In this role, she provided strategic consulting services and worked with clients to bring innovative medical products to patients. Last year, the agency convinced her to return to serve as associate deputy commissioner under Robert Califf.

Sherman began her career with the agency in 1989 as a medical reviewer in the Division of Antiviral Drug Products. In 1998, she was appointed deputy office director for the Office of Drug Evaluation I, and in 1999 she assumed the duties of deputy office director for the newly established Office of Medical Policy.

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

Read more

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