FDA Policy/General

FDA Policymaking May Return to Normalcy: Former FDAers

Speaking at the BIO 2026 convention, a panel of former FDA regulators praised the agency’s announcement of a pending IND pilot program as the potential start of a return to normalcy in policy making. The fact that the pilot was announced in an agency statement and solicited stakeholder feedback was praised by the panelists as a step away from the situation under former FDA commissioner Marty Makary, in which policy was announced in news releases, journal articles, and social media.

A BioSpace report on the panel discussion says Eva Temkin, formerly in the Chief Counsel’s Office and the Office of New Drugs, described a “callous disregard for policymaking in an open and transparent way.” She said the decision to post complete response letters was an example of a change that was dropped under the guise of transparency, but without engaging relevant stakeholders or fully explaining the rationale behind the decision.

Former FDAer Ritu Nalubola said she found it “shocking” to see policy pronouncements in social media posts and journal articles. She added that things became even more confusing when Makary and the CBER and CDER directors left the agency. “If the policy was announced in a journal article by two individuals who are no longer at the agency, what does that mean?” she asked. “Is it, in fact, FDA policy? Are reviewers in fact implementing that policy?”

With the IND pilot announcement and other recent guidances, she said, “It was heartwarming to see that FDA is coming back, maybe turning around, to establishing policy in a way that it’s supposed to.”

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