💊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 This guidance finalizes for implementation the draft guidance of the same title issued on December 5, 2022.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🧪FDA Announces Public Meeting on Unapproved Fluoride Prescription Drugs
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Use of Orally Ingestible Unapproved Prescription Drug Products Containing Fluoride in the Pediatric Population." The purpose of the hybrid public meeting is to seek public input on the clinical use and safety concerns associated with the use of orally ingestible unapproved prescription drug products containing fluoride in the pediatric population. The public meeting will be facilitated by the Reagan-Udall Foundation for the FDA. FDA is establishing a docket for public comment on this topic.
Learn More📋FDA Notice on Postmarket Surveillance of Medical Devices
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for postmarket surveillance of medical devices.
Learn More💊FDA Notice on BRIUMVI Patent Extension Implications
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRIUMVI 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's Patent Extension Review for ROLVEDON and Its Business Impact
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ROLVEDON 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 Notice on New Animal Drug Information Collection Activities
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More💊FDA Determines Regulatory Review Period for VOYDEYA Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOYDEYA 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's Determination of Regulatory Review Period for RIVFLOZA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RIVFLOZA 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 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 Determination of Regulatory Review Period for ZEVTERA Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEVTERA 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.
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