💊FDA Oncologic Drugs Advisory Committee Meeting Notice
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Learn More💊FDA Comment Request on Tropical Disease Priority Review Vouchers
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Tropical Disease Priority Review Vouchers.
Learn More📦FDA Export Notification and Recordkeeping Requirements Overview
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports.
Learn More📄FDA Notice on Financial Disclosure for Clinical Investigators
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💊DEA Notice on Importer Application for Controlled Substances
Unither Manufacturing 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💊Siemens Healthcare Diagnostics Applies for Controlled Substances Registration
Siemens Healthcare Diagnostics, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Skalar Pharma LLC's Application for Importing Controlled Substances
Skalar Pharma 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💊DEA Notice
SpecGx LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
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 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.
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