The FDA is implementing a new pilot program that could incentivize development of certain new drugs by dramatically shortening their regulatory reviews. But to qualify, a drug must address specified ...
The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...
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 ...
The FDA named the first nine products to undergo a new expedited review process that takes 1 to 2 months, the agency announced on Thursday. The nine companies selected to participate in the FDA ...
The U.S. Food and Drug Administration will award up to $50 million over five years to the University of North Carolina at Chapel Hill and Duke University to establish the Research Triangle Center of ...
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 ...
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