is pleased to announce that it completed its pre-submission meeting with the U.S. Food and Drug Administration ("FDA") as scheduled on March 20, 2025. The purpose of the meeting was to discuss ...
The statement confirms a report by Reuters that the Vaccine and Related Biological Products Advisory Committee meeting, scheduled for March 13, has been canceled. An FDA spokesperson said the ...
Why was this meeting canceled? It's an important meeting. What's the plan for flu vaccines this year," Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education ...
"A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee on the influenza vaccine strains for the 2025-2026 influenza season in the northern ...
What’s the plan?” he said. The FDA confirmed the cancellation in a statement sent to CNN on Thursday. “A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products ...
The purpose of the meeting was to reach agreement with the FDA on the proposed content and format of the Company’s planned sNDA submission including the clinical and nonclinical requirements.
XORTX Therapeutics (XRTX) provided an update regarding communications with the US Food and Drug Administration. At the request of the FDA a ...
Dr. Paul Offit, a member of the FDA’s Vaccine and Related Biological Products Advisory Committee, told various news outlets that the agency sent out an email Wednesday canceling a panel meeting ...
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