💉FDA Updates on Susceptibility Test Interpretive Criteria Announced
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Learn More💊Implications of New Nonprescription Drug Regulations for Businesses
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.
Learn More💊FY 2025 Facility Fee Rates for OTC Monograph Drugs Announced
The Food and Drug Administration (FDA, the Agency, or we) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). This notice publishes the OMUFA facility fee rates for FY 2025.
Learn More🚑FDA Revokes Emergency Use Authorizations for COVID-19 Diagnostic Tests
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Beckman Coulter, Inc., for the Access SARS- CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Learn More⚙️FDA Modifies Recognized Standards for Medical Devices
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 063" (Recognition List Number: 063), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Learn More💊FDA Withdraws Approval of Eight Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More💊FDA Withdraws Approval of Abbreviated New Drug Applications
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Learn More🌱FDA Accepts Impossible Foods' Color Additive Petition for Plant-Based Products
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to expand the safe use of soy leghemoglobin as a color additive to include use in plant-based meat, poultry, and fish analogue products (ground and whole cut).
Learn More⚖️FDA Denies Hearing and Issues Permanent Debarment for Garmendia
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Bernardo Garmendia, also known as Bernardo Germendia, (Garmendia) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Garmendia from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Garmendia was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. FDA provided notice to Garmendia of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Garmendia submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Learn More💊FDA Withdraws Approval for ZULRESSO (Brexanolone) Solution
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for ZULRESSO (brexanolone) solution, 100 milligrams (mg)/20 milliliters (mL), held by Sage Therapeutics, Inc., 55 Cambridge Parkway, Cambridge, MA 02142 (Sage). Sage notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
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