The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
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 up construction and review of ...
FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.
A new drug application (NDA) and a biologics license application (BLA) have been resubmitted and accepted by the FDA for ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
The FDA launched PreCheck pilot program to strengthen U.S. drug supply chain by improving regulatory predictability.
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.
Welcome to Fierce Pharma's regulatory tracker for the first half of 2026. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results