HHS · Notice · Rel 100 (Federal Register (major agencies))
Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY
Other · Health / life sciences · general, public-health, fda-guidance
Source summary
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.
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