On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot ...
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission ...
FDA Commissioner Marty Makary, M.D., M.P.H., characterized the program as a “bold step” to bring manufacturing back to the US and make the domestic sector more resilient and competitive. This program ...
Like much of the federal government, the Food and Drug Administration has faced several program cuts and changes under the Trump administration’s sweeping changes to the bureaucracy. In the most ...
FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.
Aurobindo Pharma Ltd ( (IN:AUROPHARMA)) just unveiled an update. Aurobindo Pharma Limited announced the completion of a US FDA inspection at Unit-IV of its subsidiary, APL Healthcare Limited, located ...
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...
When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...
Add Yahoo as a preferred source to see more of our stories on Google. Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of ...
The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while reducing staff hours by 20%. Real-time risk mitigation is enabled through ...
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