💊FDA Determines Regulatory Review Period for ELREXFIO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELREXFIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💊Notice of Proposed Production Activity for Pfizer in FTZ 43
Pfizer, Inc. has submitted a notification for proposed production activity within Foreign-Trade Zone (FTZ) 43E in Kalamazoo, Michigan, involving the manufacturing of a pharmaceutical intermediate product. This notification outlines the specific foreign-status materials and production benefits available under FTZ procedures, inviting public comments regarding this proposal.
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