The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision ...
The Food and Drug Administration (FDA) lacks certain authorities and is persistently underresourced to fulfill its mission of protecting the public by ensuring that foods are safe, wholesome, sanitary ...
“Unfortunately, the additional fees may induce a chilling effect on filing continuing applications. [But] by understanding the new fee structure and adjusting their filing practices accordingly, ...
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