💊FDA Notice on JOENJA Regulatory Review and Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JOENJA 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 Notice on Regulatory Review Period for VELSIPITY Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VELSIPITY 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 Regulatory Review Period Determination for TRUQAP
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRUQAP 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 Advisory Committee on REXULTI
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Psychopharmacologic 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.
Learn More💊FDA Notice on Regulatory Review Period for XOLREMDI Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XOLREMDI 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 Issues Regulatory Review Period for VOWST Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOWST 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💊FDA Issues Guidance on Prioritized Generic Drug Submissions
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions." This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA will use this information to set a review goal for a priority abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments (GDUFA) and as described in "GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027" (GDUFA III commitment letter). This guidance finalizes for implementation the draft guidance of the same title issued on December 5, 2022.
Learn More💊American Radiolabeled Chem's Controlled Substances Manufacturing Application
American Radiolabeled Chem has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More📜Notice on Antitrust Compliance and Membership Changes in RRPV
The Department of Justice announces changes in membership for the Rapid Response Partnership Vehicle, aimed at extending antitrust protections under the National Cooperative Research and Production Act of 1993. The announcement details new members, withdrawals, and ongoing commitments to collaborative research projects, maintaining open membership for future participation.
Learn More💊ANI Pharmaceuticals Inc. Application for Controlled Substances Registration
ANI Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
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