FDA’s focus on playing a direct role in lowering drug prices may provide opportunities for some pharmaceutical companies to seek a regulatory advantage. But it also places enormous pressure on ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...
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