The US Food and Drug Administration wants advisory committee input on a new “inter-pandemic” process for updating licensed prototype pandemic influenza vaccines that is designed to make better-matched shots available prior to a pandemic.
US FDA Proposes New ‘Inter-Pandemic’ Pathway For Updating Flu Vaccines
The threat of a highly pathogenic avian influenza pandemic spurred the FDA to have its vaccine advisory committee comment on a new process to update licensed prototype pandemic flu vaccines.
More from Vaccines
• By
Only government staff participated in the meeting defining the next season’s influenza vaccine composition after the annual public FDA vaccines advisory committee meeting was cancelled.
• By
President Trump’s CDC director nominee was pulled after vaccine positions appeared too extreme for some Republicans, but the nominations to lead the FDA and NIH advanced to the Senate floor despite last-minute drama.
• By
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.
• By
US FDA Commissioner nominee Martin Makary’s 6 March Senate confirmation hearing should offer insight on his alignment with HHS Secretary Robert F. Kennedy Jr.'s views and willingness to insulate the FDA from an unusual level of micromanagement by the department and White House.
More from Product Reviews
• By
Congress continues to offer broad support for encouraging alternatives to opioid pain medicine, including proposals to speed coverage of new agents like Vertex’ Journavx.
• By
Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”
• By
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.