FDA Policy/General

CDER Drug Policy Guru Heads to Morgan Lewis

After serving at FDA for eight years, CDER Office of New Drug Policy director Maarika Kimbrell has left the agency to re-enter private legal practice at Morgan Lewis as a partner resident to counsel pharma/biotech companies on regulatory matters. Previously at FDA, she served as deputy chief of staff to former FDA commissioner Scott Gottlieb.

“Maarika has shaped FDA policy on a broad array of issues impacting the regulation of biomedical products, including accelerated approval and other expedited programs, the granting of market exclusivities, and the agency’s response to the Covid-19 public health emergency,” law firm chair Jami McKeon is quoted as saying in a news release. “Her deep FDA regulatory capability across the lifecycle of drugs and biologics, coupled with her sophisticated understanding of the life sciences industry, will be important in supporting our clients that seek growth and development opportunities in this complex industry.”

Prior to joining the agency, Kimbrell was in private practice for over nine years at Covington & Burling, and almost two years at Morrison & Foerster.

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