Industry and FDA representatives have reached a general agreement on planned pre-submission facility meetings but have expressed different views about the specifics.

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 ...

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 ...

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.

Roughly half a year after introducing the new regulatory pathway, the FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner's National Priority Voucher (CNPV) pilot ...

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.

Makary said the FDA is looking at prescription drugs like nausea medications and vaginal estrogen, and hopes to make changes this year.

About five months after U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. | About five months after U.S. Health Secretary Robert F. Kennedy Jr. touted leucovorin as “an ...

The Food and Drug Administration is expanding approval of leucovorin to treat an ultra-rare genetic condition.

"Medicare was built on evidence-based medicine," said Duane Boise, CEO of MMJ International Holdings. "If cannabinoid therapies are going to be reimbursed by federal healthcare programs, they should ...

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 ...