![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Pfizer Withdraws Application for Emergency Use of its COVID-19 Vaccine in India
Pfizer Withdraws Application for Emergency Use of its COVID-19 Vaccine in India
Pfizer withdrew its application for emergency use approval of its COVID-19 vaccine in India after the country’s regulator requested a domestic trial.
India’s vaccine regulatory authority called for a study on safety and immune responses in its population, while Pfizer sought to have the trial requirements waived based on its currently available global phase 3 data.
The company said it “remains committed to making its vaccine available” in India and plans to resubmit its approval request with additional information as it becomes available.
Upcoming Events
-
21Oct