FDA Policy/General

Ex-FDA Lawyer Temkin Joins Paul Hastings

Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin has joined Paul Hastings as chair of the firm’s FDA practice. She spent over eight years at the agency before leaving in 2021 to join King & Spaulding as a partner.

In her new role, Temkin will focus on regulatory, litigation, and transactional matters involving regulated biomedical products, according to a news release. “Temkin works on matters spanning product development and clinical trials, regulatory exclusivities, orphan drugs issues, manufacturing and facilities issues, post-approval study requirements and REMS, drug-use-related software and digital technologies, licensing and supply arrangements, the Administrative Procedure Act, and the Inflation Reduction Act,” it says.

While at the agency, Temkin led policy development related to biological products as acting director of policy for CDER’s Office of Therapeutic Biologics and Biosimilars, her bio says. “As associate chief counsel at the FDA’s Office of Chief Counsel, she provided strategic direction to the agency’s regulators on complex biomedical product issues and legislative initiatives, including the 21st Century Cures Act and over-the-counter monograph reform,” it adds.

Temkin has an undergraduate degree from the University of Michigan and a law degree from New York University School of Law.

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