FDA Policy/General

Advancing Regulatory Science at FDA 2022 Report

The 2022 Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science report highlights updates to the 2021 report. FDA commissioner Robert Califf says the updates make apparent “the incredible breadth and depth of FDA’s science base.”

Califf writes in the report’s introduction that in addition to highlighting the diverse scientific areas that must be brought to bear on regulatory decisions, “this document should convince any potential skeptics that FDA cannot do its job without extensive scientific collaboration.”

Chief scientist Namandjé Bumpus and deputy chief scientist Jacqueline O’Shaughnessy write that a key purpose of the report is to communicate the importance and impact of FDA’s cross-cutting ongoing regulatory science research activities on a regulator basis. “Because we aim to stay ahead of evolving regulatory needs,” they write, “we have reviewed each of the Focus Areas of Regulatory Science (FARS) from the 2021 report and provided important updates to the example highlights in the FARS. The ability to stay agile with regular updating ensures that the FARS includes the most current topics and examples of FDA’s regulatory science to fulfill our regulatory responsibilities.”

The 2021 report highlighted cross-cutting priorities in women’s health, minority health, health equity across diverse groups, and the One Health Initiative, the chief scientists say. In 2022, the cross-cutting topics were increased to cover pediatric health, rare diseases, and oncology.

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