💊FDA Issues Priority Review Voucher for EBANGA Medical Countermeasure
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that EBANGA (ansuvimab-zykl) for injection, approved on December 21, 2020, manufactured by Ridgeback Biotherapeutics, LP, meets the criteria for a material threat MCM priority review voucher.
Learn More💊FDA Approves EYLEA HD with Priority Review Voucher
The Food and Drug Administration (FDA) is announcing the 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 material threat medical countermeasure (MCM) 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 application for EYLEA HD (aflibercept), approved August 18, 2023, meets the criteria for redeeming a priority review voucher.
Learn More🏭FDA Announces QMM Assessment Protocol Evaluation Program for Drug Manufacturers
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program.
Learn More🍼FDA Guidance on Lead Levels in Food for Babies and Young Children
The Food and Drug Administration (FDA) is correcting a notice of availability that appeared in the Federal Register on January 7, 2025. The document announced the availability of a final guidance for industry entitled "Action Levels for Lead in Processed Food Intended for Babies and Young Children." The notice published with an error in the Background section. This document corrects the error.
Learn More💊FDA Announces Joint Meeting on Opioid Analgesics Regulation
The Food and Drug Administration (FDA) is announcing an amendment to the notice of joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. This meeting was announced in the Federal Register of December 9, 2024. The amendment is being made to reflect changes in the DATES, ADDRESSES, and Procedure portions of the document. There are no other changes.
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 Approves TREMFYA Under Rare Pediatric Disease 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-24) for TREMFYA (guselkumab), approved March 20, 2025, meets the criteria for redeeming a priority review voucher.
Learn More💊FDA Decision on MOBIC Allows Continued Generic Approvals
The Food and Drug Administration (FDA or Agency) has determined that MOBIC (meloxicam) tablets, 7.5 milligrams (mg) and 15 mg, were 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.
Learn More💉FDA Updates on Susceptibility Test Interpretive Criteria Announced
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Learn More💊FDA Withdraws Approval of 23 ANDAs from Teva Pharmaceuticals
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 15, 2025. The document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 14, 2025. The document indicated that FDA was withdrawing approval of the ANDA 209325 for miglustat capsule, 100 milligrams, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Suite 201, Berlin, CT 06037. Before FDA withdrew the approval of this ANDA, Breckenridge Pharmaceutical, Inc. informed FDA that they did not want the approval of the ANDA withdrawn. Because Breckenridge Pharmaceutical, Inc., timely requested that approval of ANDA 209325 not be withdrawn, the approval is still in effect. This notice corrects this error.
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