US Advisory Committees
All RSV vaccines with US FDA approval for high-risk younger adult patients will be incorporated in US CDC’s Advisory Committee for Immunization Practices recommendations. Merck’s infant RSV antibody is on track for a June vote
Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.
Most, if not all, adcomm support staff in the drug and biologic centers who handled meeting-specific tasks have been laid off, although sponsors still are preparing for the public reviews. Meanwhile, some cut FDA employees are being called back to work for "continuity of operations activities."
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The disruption of CDC’s Advisory Committee on Immunization Practices meeting schedule adds fuel to concerns about potential alterations of the vaccine schedule raised by former FDA Commissioner Scott Gottlieb.
Martin Makary said he would re-evaluate the topics that deserve a Vaccines and Related Biological Products Advisory Committee review, but did not commit to rescheduling the cancelled meeting on influenza vaccine strain selection.
The Vaccines and Related Biological Products Advisory Committee meeting next month was scheduled to select strains for the 2025-2026 flu vaccine. The cancellation could mean delays in vaccine availability.
The February meeting of US CDC’s Advisory Committee on Immunization Practices was indefinitely delayed to accommodate public comment, which did not open as scheduled on 3 February.
Pink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.
HHS communications restrictions are keeping the FDA from publicly scheduling expected advisory committee meetings. The lack of upcoming meetings is raising concern about missed user fee dates or lower-quality agency decision-making.
A Trump Administration communications freeze and travel ban may be complicating efforts to convene FDA advisory committees. A 5 February meeting on postmarketing requirements for extended-release/long-acting opioids was postponed, while a 24 February meeting on a Novartis rare disease drug was cancelled.
The injection for radicular leg pain appears likely to be approved, but with a very prescriptive label to help balance safety concerns and a lack of long-term outcomes data.
An FDA advisory committee will consider modifications to the indicated patient population, as well as the appropriate health professionals and settings to administer the proposed treatment for radicular leg pain.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The development of a joint document is not iterative and there is no discussion between the agency and sponsor, according to new guidance seemingly aimed at differentiating the frequent use of joint backgrounders in oncology from the single document developed for the Alzheimer's drug Aduhelm.
A safety signal may be platform or even Moderna-specific, the Vaccines and Related Biological Products Advisory Committee said.
The FDA wants to update 2017 requirements for the data needed before initiating RSV vaccine trials in infants and toddlers after vaccine-associated enhanced respiratory disease triggered an indication-wide research hold.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The FDA and sponsors should have surveyed providers and patients who do not prescribe or use the antipsychotic clozapine to find whether the REMS restrictions were hindering access and causing harm, advisory committee members and patient advocates said.
The agency reaffirmed support for a hemoglobin A1C endpoint for glycemic control in type 1 diabetes, but the diabetic ketoacidosis risk with sotagliflozin is so concerning that it is looking for additional benefits in patients with chronic kidney disease, a targeted subpopulation.