The FDA will begin accepting applications Feb. 1 for its PreCheck pilot program, an initiative designed to strengthen the domestic pharmaceutical supply chain. The program aims to increase regulatory ...
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...
The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while ...
Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
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 ...
ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. U.S. inspectors have uncovered new and dangerous ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...
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