💊FDA Decision on ETHYOL
The Food and Drug Administration (FDA, the Agency, or we) has determined that ETHYOL (amifostine) for injection, 500 milligrams (mg)/ vial, was not withdrawn from sale for reasons of safety or effectiveness.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.
Learn More🐾FDA Reopens Comment Period for Type VII Veterinary Master File Guidance
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice announcing the availability of a draft guidance for industry (GFI) that appeared in the Federal Register of January 7, 2025. In that notice, FDA requested comments on draft GFI #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments before the agency begins work on the final version of the guidance.
Learn More💊FDA Confirms NASCOBAL Status, Impacting Generic Approvals
The Food and Drug Administration (FDA, Agency, or we) has determined that NASCOBAL (cyanocobalamin) nasal spray, 0.5 milligram (mg)/spray, was not withdrawn from sale for reasons of safety or effectiveness.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.
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document announced the withdrawal of approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of February 14, 2025.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approval of this ANDA, Breckenridge Pharmaceutical, Inc. informed FDA that they did not want the approval of the ANDA withdrawn.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.
Learn More⚛️NRC Withdraws Regulatory Guide on Decommissioning Plans
The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 3.65, "Standard Format and Content of Decommissioning Plans for Materials Licensees." This RG is being withdrawn because it is not needed to endorse NUREG-1757, "Consolidated Decommissioning Guidance: Decommissioning Process for Materials Licensees," Volume 1, "Decommissioning Process for Materials Licensees." NUREG-1757 provides the most current guidance on decommissioning nuclear facilities to support license termination for applicants, licensees, and NRC staff reviewers.
Learn More🧠Amended Notice of Meeting for NIH Center for Scientific Review
This document provides a notice of a scheduled meeting for the Center for Scientific Review's Special Emphasis Panel on Brain Disorders and Related Neurosciences, detailing changes in the meeting's contact person and confirming that it will not be open to the public.
Learn More⚡Notice of Application for Loup River Hydroelectric Project License
The Federal Energy Regulatory Commission has announced the application for a non-capacity amendment of the Loup River Hydroelectric Project license. The notice invites comments and interventions regarding proposed changes to operational flow requirements and monitoring for environmental impacts, emphasizing the involvement of federal, state, and local agencies.
Learn More📦Notice of USPS Product Change for Priority Mail and Ground Advantage
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Learn More📦USPS Notice on Priority Mail & Ground Advantage Service Changes
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Learn More📡FCC Petitions for Reconsideration
The Federal Communications Commission is correcting a Petition for Reconsideration (Petitions) that appeared in the Federal Register on March 14, 2025. The document, which invited comment on the Petitions filed in the Commission's rulemaking proceeding, incorrectly listed the date by which replies to an opposition to the Petitions must be filed.
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