💊FDA Issues Draft Guidance for Developing Drugs for Erosive Esophagitis
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.
Learn More💊Catalent Greenville Inc. Applies for Controlled Substances Import License
Catalent Greenville, Inc. 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💊DEA Notice on Fisher Clinical Services' Importer Application
Fisher Clinical Services, Inc. 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⚖️Cambridge Isotope Laboratories Applies for Controlled Substances Import
Cambridge Isotope Laboratories, Inc. 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💊Drug Enforcement Administration Notice on Fresenius Kabi Application
Fresenius Kabi USA, 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 Guidance on Biosimilar Classification Categories Released
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Classification Categories for Certain Supplements Under BsUFA III." This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications for biosimilar and interchangeable biosimilar products under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.
Learn More💊VA Cooperative Studies Program Seeks Registration as Controlled Substance Importer
VA Cooperative Studies Program 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🚫Amylyx Pharmaceuticals' RELYVRIO Drug Approval Withdrawn by FDA
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for RELYVRIO (sodium phenylbutyrate and taurursodiol) for suspension, 3 gram (g)/ packet and 1 g/packet, held by Amylyx Pharmaceuticals, Inc. (Amylyx), 43 Thorndike St., Cambridge, MA 02141. Amylyx has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.
Learn More❌FDA Terminates Arthritis Advisory Committee – Regulatory Update
The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Arthritis Advisory Committee (Committee). Due to that termination, this final rule removes the Committee from the Agency's list of standing advisory committees in 21 CFR 14.100.
Learn More🍀FDA Issues Priority Review Voucher for Rare Pediatric Drug
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. 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 award of the priority review voucher. FDA has determined that MODESYO (dordaviprone), approved August 6, 2025, manufactured by Chimerix, Inc., meets the criteria for a priority review voucher.
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