US Food and Drug Administration
@usfda
Announcements from the US Food and Drug Administartion. Not an official account!
FDA releases annual lists of self-identified generic drug facilities and sites from FY 2014 to FY 2026...
FDA updates NDC Directory with new drug, compounded, and unfinished drug data; no approval implied. ...
Recall of Honey Energy Support contains undeclared tadalafil...
FDA issues warning to Kirkman for CGMP violations after 2025 inspection; inadequate change control, process validation, and stability testing identified....
FDA issues warning for Flextronics over CGM manufacturing violations...
FDA issues warning to Carolina Seafood for HACCP violations in seafood dips...
FDA issues warning to quail egg processor for repeated violations of acidified foods regulations and failure to register facility. ...
FDA issues warning to CC Pollen for CGMP violations and misbranding of dietary supplements...
FDA issues warning to Eniva USA for CGMP violations and adulteration of dietary supplements...
FDA issues warning to African food importer for failing to develop and maintain FSVP compliance, risking import bans and detention. ...
FDA issues warning for unapproved nicotine pouch products sold online...
FDA issues warning to Unomedical Device for CGMP violations and unvalidated leak tests on insulin infusion sets. ...
FDA issues warning to Abbott Diabetes Care for CGMP violations in glucose monitoring device manufacturing...
FDA releases 2024 Drug Trials Snapshots highlighting demographic participation and trial data for new drug approvals. ...
FDA approves 46 new drugs in 2025 across diverse therapeutic areas including oncology, rare diseases, and cardiovascular conditions. ...
FDA outlines disclosure agreement process for rare disease endpoint development, emphasizing transparency and data protection. ...
FDA issues warning to Eurosirel S.P.A. over CGMP violations including inadequate component testing and quality oversight...
Eurosirel S.P.A. clears FDA warning letter after addressing violations...
FDA updates on drug development tool qualification projects show 151 in progress, 20 qualified, with recent additions across biomarker and clinical outcome programs....
FDA extends GDUFA III reauthorization through September 2027, with new fee structures and electronic payment mandates starting October 2025. ...
FDA updates FY 2025-2026 PDUFA fee rates and payment deadlines; electronic payments now mandatory starting October 1, 2025....
FDA emphasizes safety oversight in human drug compounding amid risks and access concerns...
FDA enhances electronic registration and listing compliance with surveillance, data validation, and enforcement actions including warning letters. ...
FDA warns consumers: Umary products contain hidden diclofenac and omeprazole, risking cardiovascular, gastrointestinal, and skin adverse effects. ...
Multiple pain and arthritis products flagged for containing hidden drug ingredients, posing safety risks; ongoing recalls and alerts issued. ...
FDA approves first oral drug for pediatric anemia in thalassemia and a new therapy for rare blood disorder; updates drug shortage data and Orange Book....
FDA launches Rare Disease Innovation Hub to accelerate treatments for 30M+ Americans; focuses on small populations and variable disease natural history...
FDA releases updated Drugs@FDA database with 12 tables, latest data as of Feb 3, 2026, enabling detailed drug info analysis....
US launches comprehensive review of pharmaceutical supply chains amid resilience efforts...
FDA issues warning to Kirkman for CGMP violations after 2025 inspection; inadequate change control, process validation, and stability data prompt potential recalls....
FDA issues warning letter to Cohance Lifesciences for CGMP violations including inadequate investigation, cross-contamination risks, and improper cleaning procedures at Hyderabad facility....
FDA finalizes QMSR harmonizing ISO 13485:2016 with 21 CFR part 820; updates access policies for quality assurance audits effective Feb 2026. ...
FDA reports zero hires for FY26 PDUFA VII biologics center and FY26 BsUFA III, with ongoing hiring gaps from FY25-FY23....
False positive lead results linked to ASP Global’s capillary tubes with LeadCare systems prompt FDA warnings and investigations. ...
Early alert on Abiomed Impella RP devices warns of sensor malfunction risking inaccurate flow data; clinical monitoring essential. ...
Allergy recall: Undeclared wheat and sesame in FU ZHOU FISH BALLs from Koikoi Trading prompts product withdrawal. ...
Neogen recalls all lots of Vet HYCOAT Hyaluronate Sodium Solution due to microbial contamination risks...
Houston-based Why Not Natural recalls Moringa Green Superfood over Salmonella risk...
FDA launches PreCheck pilot to boost U.S. pharma manufacturing; aims for 2026 rollout with focus on critical meds and innovation...