💊FDA Meeting on Reauthorization of Prescription Drug User Fee Act
The Food and Drug Administration (FDA, the Agency, or we) is hosting a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028 through 2032. These comments will be published and available on FDA's website.
Learn More💊FDA Notice on NGENLA Regulatory Review Period and Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NGENLA 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 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💊FDA Notices Regulatory Review Period for JAYPIRCA Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for JAYPIRCA 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 SUNLENCA Regulatory Review Period and Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SUNLENCA 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 Seeks Stakeholder Participation for PDUFA Reauthorization
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Learn More💊FDA Notice on Pharmaceutical Supply Chain Compliance Requirements
The Food and Drug Administration (FDA, the 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 (PRA).
Learn More💊NIH Notice of Closed Meeting for Drug Product Development Proposals
The Department of Health and Human Services announces a closed meeting of the National Center for Advancing Translational Sciences Special Emphasis Panel to review contract proposals related to chemistry, manufacturing, and controls for drug product development. The meeting will take place via video format and is not open to the public.
Learn More💊FDA Approves AMVUTTRA Under Priority Review Voucher
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application (Supplement-06) for AMVUTTRA (vutrisiran), approved March 20, 2025, meets the criteria for redeeming a priority review voucher.
Learn More💊FDA Confirms DECADRON Not Withdrawn for Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that DECADRON (dexamethasone sodium phosphate) solution/ drops, equivalent to (EQ) 0.1 percent phosphate, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
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