This analysis reviews the history and current status of biosimilar regulation in the US, concluding that changing the FDA’s interchangeability standards—as proposed by some policy makers—is a ...
Automatic translators can facilitate migration from C to Rust, but existing translators generate unsatisfactory code by ...
Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...
The U.S. Food and Drug Administration said on Friday that it has launched a new pilot program to speed up the review process for generic drugs that are tested and manufactured entirely in the United ...
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. REUTERS/Dado Ruvic/Illustration (Reuters) -The U.S. Food and Drug ...
The U.S. Food and Drug Administration has launched a new pilot program to speed up the review process for generic drugs that are tested and manufactured entirely in the United States, the regulator ...
US FDA Launches Pilot Program to Fast-Track Review of Domestically Made Generic Drugs (Reuters) -The U.S. Food and Drug Administration said on Friday it has launched a new pilot program to speed up ...
Copyright 2025 The Associated Press. All Rights Reserved. Copyright 2025 The Associated Press. All Rights Reserved. The Food and Drug Administration seal is seen at ...
The FDA's pilot program aims to expedite reviews for domestically manufactured generic drugs, enhancing the U.S. pharmaceutical supply chain and reducing costs. The initiative requires ANDA applicants ...
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