US Advisory Committees
With the US CDC Advisory Committee on Immunization Practices sidelined by the courts, the Pink Sheet imagined how a past version of the panel may have spent the spring, including tracking a fast‑moving pipeline of flu, RSV, Lyme, dengue, and next‑generation combination vaccines.
Vaccine manufacturers warned the FDA vaccines advisory committee that international genetic resource rules are delaying influenza virus sharing and creating regulatory hurdles that could undermine seasonal vaccine preparedness.
Trivalent formulations for the 2026-2027 northern hemisphere flu season address the swift rise of subclade K, but the persistent need for broader antigen coverage keeps quadrivalent possibilities in mind.
Significant viral drift and a temporarily rebuilt committee set the stage for a high‑stakes VRBPAC vote on updates to the three influenza vaccine strains for the 2026–2027 season.
Advisory committees are costly, slow, full of “pomp and flash” and panelists do not do their homework, a senior FDA official said just hours before the agency announced plans for an April 30 Oncologic Drugs Advisory Committee meeting on two AstraZeneca applications.
Recent and upcoming FDA advisory committee meetings and a summary of the topics covered.
Posting action packages for rejected products, not just the complete response letters, is a provocative idea, but also a reminder of what the FDA has lost by not holding many advisory committees during the Trump Administration.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New terms of reference for the Advisory Committee on Immunization Practices’ overhauled work groups on influenza, HPV and RSV reflect some members' broader concerns about the potential long-term adverse effects of vaccination.
A workshop co-hosted by the US FDA and Duke on ideas to expand access to epinephrine for anaphylaxis is the latest example of the agency holding a public meeting that could have been an advisory committee – but without the formalities.
After conducting more than 30 meetings for drugs, biologics and related issues in 2023 and 2024, less than half as many were held in 2025.
The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.
At a CDC vaccine advisory committee criticized for “promoting an anti-vaccine agenda,” the new CDER director championed the committee’s plans and suggested the FDA would make more frequent vaccine label updates due to revised safety frameworks.
Because combination vaccines remain in the US childhood vaccine schedule, ACIP's reconsideration of hepatitis B vaccine dose timing could impact uptake of other immunizations, Demetre Daskalakis told the Pink Sheet.
From how he will interact with industry to his staff, to a possible advisory committee revival and dangling accelerated approval crackdowns, Pink Sheet looks at how Rick Pazdur's oncology track record could translate to CDER.
Formal meetings like application orientation sessions or patient listening sessions are becoming increasingly important as the FDA schedules fewer advisory committee meetings for applications, experts said.
Unanimous vote on trivalent Southern hemisphere 2025-2026 influenza vaccine composition by US FDA advisory committee agrees with World Health Organization, but committee members want to keep quadrivalent capacity available
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The risks, as well as the benefits, of vaccination could be long-term, Advisory Committee on Immunization Practices member Retsef Levi said. The FDA’s Tracy Beth Høeg also said long-term safety data are needed to inform the benefit-risk analysis of the hepatitis B birth dose.
The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.