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FDA-RELATED NEWS
 
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TXT Aspen Pharmacare CGMP Violations
03/19/2025
 
 
TXT FDA Accepts Alvotech AVT03 BLA
03/19/2025
 
 
TXT CGMP Violations at Canada’s Vegewax Candleworx
03/19/2025
 
 
TXT Smiths Medical Recalls Venous Access System
03/19/2025
 
 
TXT 2 ICH Guidelines Advance
03/19/2025
 
 
TXT Keytruda Full Approval for Gastroesophageal Cancer
03/19/2025
 
 
TXT Sarepta Reports Death Linked to Elevidys
03/18/2025
 
 
TXT Balance Drug Approval Flexibility, Evidence: Study
03/18/2025
 
 
TXT Physician-Investigator ‘Objectionable Conditions’
03/18/2025
 
 
TXT Advanced Pharmaceutical Repeat CGMP Violations
03/18/2025
 
 
TXT FDA Outlines Concerns with Unapproved GLP-1 Drugs
03/18/2025
 
 
TXT Medtronic Recalls Vantage Embolization Devices
03/18/2025
 
 
TXT FDA Rehires Fired Employees Due to Court Order
03/18/2025
 
 
TXT Incyte Plans NDA for JAK1 Inhibitor for Skin Condition
03/17/2025
 
 
TXT Ex-Magellan Execs Plead Guilty in Device Scandal
03/17/2025
 
 
TXT Hold Removed on vTv Therapeutics Diabetes Trial
03/17/2025
 
 
TXT Positive Hypoparathyroidism Trial Data: AstraZeneca
03/17/2025
 
 
TXT Thousands of FDA Employees Return to Office
03/17/2025
 
 
TXT Korro Bio Gets Orphan Status for KRRO-110
03/14/2025
 
 
TXT FDA Panel Determines Next Flu Vaccine Composition
03/14/2025
 
 
TXT Dr. Reddy’s Recalls Mislabeled Seizure Drug
03/14/2025
 
 
TXT CareFusion Recalls BD Alaris Systems Manager
03/14/2025
 
 
TXT FDA Top Lawyer Resigns After 2 Days on the Job
03/13/2025
 
 
TXT SpringWorks Therapeutics Awarded Priority Voucher
03/13/2025
 
 
TXT Q’Apel Selling Unapproved Aspiration System: FDA
03/13/2025
 
 
TXT One-third of MAUDE Reports Submitted Late: Study
03/13/2025
 
 
TXT Senate Committee Advances Makary’s FDA Nomination
03/13/2025
 
 
TXT Returning FDA Staff to Face Space, Parking Issues
03/13/2025
 
 
TXT Amgen Seeking Expanded Uplizna Use
03/13/2025
 
 
TXT FDA Device Data Integrity Notifications
03/13/2025
 
 
TXT CGMP Deviation in Chemspec Chemicals Inspection
03/12/2025
 
 
TXT 7 Acne Products Recalled for Benzene: FDA
03/12/2025
 
 
TXT Regulate NarxCare as Software as Medical Device: Petition
03/12/2025
 
 
TXT DoJ Lawyer Tapped as FDA Chief Counsel
03/12/2025
 
 
TXT Zenrelia Promotions ‘False and Misleading’: FDA
03/12/2025
 
 
TXT FDA Safety Alert on Immune Globulin Products
03/12/2025
 
 
TXT Beckman Coulter 510(k) Cleared for Clinical Analyzer
03/11/2025
 
 
TXT CGMP Deviations at Shree Jaya Unit
03/11/2025
 
 
TXT Linghai ZhanWang Records Show CGMP Violations
03/11/2025
 
 
TXT FDA Rejects All Mid-Link Technology Data
03/11/2025
 
 
TXT Clinical Researchers Plead Guilty to Fraud
03/11/2025
 
 
TXT FDA Warns 6 Firms on Unapproved Fat-Dissolving Drugs
03/11/2025
 
 
TXT Top Device Science Official Leaves FDA
03/11/2025
 
 
TXT Glenmark Pharma Hit With 483 After India Inspection
03/10/2025
 
 
TXT FDA Taps Jim Traficant as Chief of Staff
03/10/2025
 
 
TXT Mineralys Nets Positive Data in Hypertension Drug Studies
03/10/2025
 
 
TXT Dexcom Hit With Warning After 2 Inspection
03/10/2025
 
 
TXT FDA Staff Given $25,000 Buyout Offers
03/10/2025
 
 
TXT FDA Clears Zimmer Persona Knee Implant
03/07/2025
 
 
TXT Fresenius Kabi Recalls Ivenix Infusion Software
03/07/2025
 
 
TXT J&J Stops Phase 3 Depression Drug Program
03/07/2025
 
 
TXT FDA Domestic Inspections Fall, Foreign Rise: Study
03/07/2025
 
 
TXT Celltrion BLA for Interchangeable Xolair Biosimilar
03/07/2025
 
 
TXT FDA Nixes Vanda Hetlioz Hearing
03/06/2025
 
 
TXT Nuwellis AquaFlexFlow Recall is Class 1
03/06/2025
 
 
TXT FDA OKs Gene Therapy for Retinal Disease
03/06/2025
 
 
TXT Micro Therapeutics Recalls Embolization Device
03/06/2025
 
 
TXT Opportunities for Drug Development Dynamic Tools
03/06/2025
 
 
TXT 2 FDA Designations for Phantom Neuro Platform
03/06/2025
 
 
TXT Makary Pledges FDA Staff Assessment Due to Firings
03/06/2025
 
 
TXT Baxter Infusion Pump Issue Early Alert
03/05/2025
 
 
TXT Orphan Drug Designation for Faron’s Bexmarilimab
03/05/2025
 
 
TXT Roche Files sBLA for Gazyva in Lupus
03/05/2025
 
 
TXT Indian-Made Generics Have Higher Risk: Study
03/05/2025
 
 
TXT FDA Clinical Hold on BioNTech Malaria Vaccine
03/05/2025
 
 
TXT CGMP Violations at Granules India Limited
03/04/2025
 
 
TXT Comments on Protocol Deviations Guidance
03/04/2025
 
 
TXT Makary To Divest Extensive Holdings: Ethics Report
03/04/2025
 
 
TXT Chem-Tech Inspection Violations
03/04/2025
 
 
TXT Capricor BLA for Duchenne-related Cardiomyopathy
03/04/2025
 
 
TXT Celltrion’s Prolia and Xgeva Biosimilars Approved
03/04/2025
 
 
TXT Regulated Companies Fear FDA Cuts Impact
03/04/2025
 
 
TXT Musk’s DOGE Cancels Leases on 30 FDA Field Offices
03/04/2025
 
 
TXT OPDP Hits Edenbridge Pharma Over Promos
03/04/2025
 
 
TXT Corcept Files NDA for Cushing’s Syndrome Drug
03/03/2025
 
 
TXT Rusfertide Phase 3 Data Meet Endpoints
03/03/2025
 
 
TXT Lexicon Taps Pilavapadin 10mg for Phase 3
03/03/2025
 
 
TXT PharmaTher Resubmits Ketamine NDA
03/03/2025
 
 
TXT Boston Scientific Recalls Pacemakers
03/03/2025
 
 
TXT Philips Recalls Tack Endovascular Device
03/03/2025
 
 
TXT PhRMA Seeks Changes to Protocol Deviations Guide
03/03/2025
 
 
TXT Olympus Recalls Endoscope Guide Sheaths
02/28/2025
 
 
TXT Labeling Changes for Testosterone Products: FDA
02/28/2025
 
 
TXT Lawyers Say Government Shutdown Could Stall Reviews
02/28/2025
 
 
TXT Zevra Selling Priority Voucher for $150 Million
02/28/2025
 
 
TXT ROi CPS Recalls Newborn Kits
02/28/2025
 
 
TXT Praxis to Finish Study Despite Data Miss
02/28/2025
 
 
TXT Bill to Block LDT Regulation
02/27/2025
 
 
TXT FDA Warns India’s Granules Generic Drug Company
02/27/2025
 
 
TXT Ventec Recalls VOCSN Ventilators
02/27/2025
 
 
TXT Makary FDA Confirmation Hearing Set for 3/6
02/27/2025
 
 
TXT FDA Suddenly Cancels Crucial Flu Vaccine Meeting
02/27/2025
 
 
TXT Fast-Track for Adicet Systemic Sclerosis Drug
02/27/2025
 
 
TXT 19-Page Exela Pharma Sciences FDA-483
02/27/2025
 
 
TXT 7 Observations in Zhejiang Huahai FDA-483
02/27/2025
 
 
TXT 6 Observations on Piramal Pharma FDA-483
02/26/2025
 
 
TXT Indoco Remedies FDA-483 Released
02/26/2025
 
 
TXT Camizestrant in Breast Cancer Meets Primary Endpoint
02/26/2025
 
 
TXT Google Watch Cleared for ‘Pulse Loss’ Detection
02/26/2025
 
 
TXT CDER Touts FY 2024 Drug Safety Activities
02/26/2025
 
 
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The most authoritative FDA news analysis each week is found in the pages of Dickinson's FDA Review. Since 1984, this newsletter has been providing in-depth reports on the most significant FDA developments affecting the pharmaceutical, medical device, biologics and veterinary medicines industries. Unlike other media, FDA Review eliminates time-wasting minutia and presents in clear, concise language the essence of what's really important - and why. It is the publication that FDA officials themselves read. Delivered in the middle of each week, FDA Review presents:
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  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
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