Drugs

Greenleaf Health Hires 2 Former FDA Officials

Regulatory consulting firm Greenleaf Health has hired two former FDA officials — former Office of Compliance Don Ashley and former FDA Europe Office deputy director Sandra Kweder. Ashley retired 11/2022 after more than 29 years in federal service, including the 25 years at FDA and the last six as director of CDER’s Office of Compliance. Kweder also retired 11/2022 after 33 years at the agency, including the past six years at the European Office. She joined the agency in 1988 as a medical officer in the Division of Antiviral Drug Products and worked her way up to Office of New Drugs deputy director, where she spent 14 years before moving to Europe.

At Greenleaf, Kweder will serve as principal of the Drug and Biological Products team, and Ashley will serve as Executive vice president of the Regulatory Compliance team. “Kweder and Ashley each bring unique subject matter expertise that expands Greenleaf's unmatched regulatory advising capabilities,” the firm says.

Greenleaf has assembled one of the largest collections of former FDA officials in the consulting industry (see staff listing).

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