📦FDA Review of Export Notification and Recordkeeping Requirements
The Food and Drug Administration (FDA) 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 Information Collection on Infectious Disease in Xenotransplantation
The Food and Drug Administration (FDA) 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 Medical Device Reporting Requirements and Compliance Overview
The Food and Drug Administration (FDA) 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 Notice on Tropical Disease Priority Review Vouchers Collection
The Food and Drug Administration (FDA) 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 Notice on Tobacco Products User Fees and Data Submission Requirements
The Food and Drug Administration (FDA) 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 Notice on Foreign Supplier Verification Program for Food Importers
The Food and Drug Administration (FDA) 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 Notification Procedures for Dietary Supplements
The Food and Drug Administration (FDA) 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 Notice on Compounding Animal Drugs from Bulk Substances
The Food and Drug Administration (FDA) 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 Information Collection Approvals and Business Implications
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More💊FDA Revokes Emergency Use Authorizations for COVID-19 Drugs
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Regeneron Pharmaceuticals, Inc. (Regeneron) for REGEN-COV (casirivimab and imdevimab administered together), to GlaxoSmithKline LLC (GSK) for sotrovimab, to Eli Lilly and Company (Lilly) for bebtelovimab, and to AstraZeneca Pharmaceuticals LP (AstraZeneca) for EVUSHELD (tixagevimab co-packaged with cilgavimab). FDA revoked these Authorizations on December 13, 2024, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, including an explanation of the reasons for the revocations, are reprinted in this document.
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