Simtra BioPharma Solutions was issued a warning letter by the FDA after an inspection uncovered a number of problems at the ...

The Trump administration recently celebrated one year of embracing the movement to Make America Healthy Again. Unfortunately, ...

On Feb. 1, 2026, the FDA officially launched its Manufacturing PreCheck Pilot Program, which is intended to de-risk and accelerate the establishment of U.S. pharmaceutical manufacturing facilities by ...

The FDA PreCheck program, first announced in August, aims to streamline review of domestic pharmaceutical plants and eliminate unnecessary ‌regulatory requirements, in line with ⁠President Donald ...

Add Yahoo as a preferred source to see more of our stories on Google. A U.S. flag, a U.S. Food and Drug Administration (FDA) logo, a syringe and a vial are seen in this illustration taken May 13, 2025 ...

FDA replaces seven fragmented adverse event databases with AEMS, enabling real-time safety signal access for pharmaceutical manufacturers and researchers. On March 11, the FDA launched a unified ...

Since 2000, pharmaceutical manufacturing has increasingly moved offshore. Today, approximately 53% of brand drug products and 69% of generics have at least one manufacturer outside the United States.

More than 400 cartons of Nilotinib capsules were voluntarily recalled by Cipla USA after failing manufacturing specifications ...

The FDA began accepting requests Feb. 1 to participate in its PreCheck pilot program, an initiative aimed at streamlining regulatory review for new U.S.-based pharmaceutical manufacturing facilities.

WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding ...