📄FDA Notice on Tobacco Health Document Submission Compliance
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 Vaccines and Biological Products Advisory Committee Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products 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 Guidance on Safety Labeling Changes for Drug Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act." This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug that FDA determines should be included in the labeling of the drug. This guidance is being updated and reissued in draft to, among other things, include the addition of information related to Congress' 2018 changes to the definition of adverse drug experience regarding reduced effectiveness and make other changes to reflect current Agency processes and procedures regarding safety labeling changes. This draft guidance revises and, when finalized, will replace the guidance for industry entitled "Safety Labeling Changes--Implementation of Section 505(o)(4) of the FD&C Act" issued in July 2013.
Learn More🌍FDA Environmental Impact Requirements for Business Applications
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 and USDA Extend Comment Period on Ultra-Processed Foods
FDA and USDA (we) are extending the comment period for the notice that appeared in the Federal Register of July 25, 2025. In the notice, we requested data and information to help develop a uniform definition of ultra-processed foods (UPF or UPFs). In response to requests for an extension, we are extending the comment period until October 23, 2025, to allow interested persons additional time to submit comments.
Learn More💉FDA Regulation Vacatur and Its Impact on Laboratory Developed Tests
On May 6, 2024, the Food and Drug Administration (FDA, the Agency, or we) issued a final rule amending the definition of "in vitro diagnostic products" in FDA's regulations. On March 31, 2025, a federal district court vacated that rule. This final rule reverts to the text of the regulation as it existed prior to the effective date of the May 2024 final rule.
Learn More🚬FDA's Information Collection on Tobacco Development Meetings
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 Debarment Order on William Goldsmith
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring William Goldsmith for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Goldsmith was convicted of one felony count under Federal law for introducing misbranded drugs into interstate commerce. The factual basis supporting Mr. Goldsmith's conviction, as described below, is conduct relating to the importation of a drug into the United States. Mr. Goldsmith was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of August 19, 2025 (more than 30 days after receipt of the notice), Mr. Goldsmith had not responded. Mr. Goldsmith's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More💰FY 2026 Priority Review Voucher Fee Rate by FDA
The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vouchers are awarded to the sponsors of tropical disease, rare pediatric disease, or material threat MCM product applications, respectively, that meet the requirements of the FD&C Act, upon FDA approval of such applications. The amount of the fee for using a priority review voucher is determined each fiscal year, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous fiscal year, and the average cost incurred in the review of an application that is not subject to priority review in the previous fiscal year. This notice establishes the FY 2026 priority review fee rate applicable to submission of eligible applications for review of human drug or biological products using a rare pediatric disease, material threat MCM, or tropical disease priority review voucher and outlines the payment procedures for such fees.
Learn More⚙️FDA Technical Amendments on Radiological Health Regulations
The Food and Drug Administration (FDA) is making technical amendments to its radiological health regulations to correct an error. On January 20, 2023, FDA published a final rule entitled "Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products" that inadvertently deleted certain existing regulatory text from the Code of Federal Regulations. This action corrects the error by restoring the inadvertently deleted regulatory text. This action is editorial in nature and is intended to ensure accuracy and clarity in FDA's regulations by restoring inadvertently deleted regulatory text.
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