💊FDA Determination on EPKINLY Patent Extension and Regulatory Review
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPKINLY 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 patents which claims that human biological product.
Learn More💊FDA's Patent Extension Determination for OMVOH
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OMVOH 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 a patent which claims that human biological product.
Learn More💊FDA Determines Regulatory Review Period for ADBRY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADBRY 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 a patent which claims that human biological product.
Learn More💊Wedgewood Pharmacy Seeks Import Registration for Controlled Substances
Wedgewood Pharmacy LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Regulatory Review Period Determination for LAMZEDE Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LAMZEDE 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 a patent which claims that human biological product.
Learn More💊FDA Announces Regulatory Review Period for SKYCLARYS Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SKYCLARYS 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 drug product.
Learn More💊FDA Determines Regulatory Review Period for LITFULO Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LITFULO 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 a patent which claims that human drug product.
Learn More🐾FDA Final Rule on New Animal Drug Regulations Effective May 2025
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
Learn More📄FDA Seeks Comments on Product Quality Communication Assessment
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Product Quality Information Request Communications Assessment: Final Report." This report fulfills a commitment under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA) to assess communication between FDA and applicants through product quality information requests during application review and to identify best practices and areas of improvement. The assessment of FDA and applicants in communicating through product quality information requests was conducted by an independent contractor, as described in the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027." As part of FDA performance commitments described in this document, FDA is publishing the final assessment report and soliciting public comments.
Learn More💊FDA Oncologic Drugs Advisory Committee Meeting Notice
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
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