Lawyers Adapt to Crop of New FDA Pilots
Joanne Hawana shared insights with Law360 Healthcare Authority about how drugmakers are responding to a series of pilot programs launched by the Food and Drug Administration. The new programs include an AI-assisted scientific review process and a program designed to accelerate the drug approval process, among other changes.
In the article, Joanne comments that she’s observed both skepticism and excitement from drugmakers and their investors in their responses to the new pilots. She notes that it would be in the best interest of companies to take advantage of the programs they qualify for despite the currently limited details about them, as failing to do so could be seen as neglect of their fiduciary duty to shareholders.
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