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FDA-RELATED NEWS
 
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TXT BIO Supports FDA’s AI/ML Discussion
08/08/2023
 
 
TXT Wegovy Hits Trial MACE Goal
08/08/2023
 
 
TXT FDA OKs Boston Scientific Cryoablation Device
08/08/2023
 
 
TXT QTc Labeling Information Guidance
08/08/2023
 
 
TXT Dräger Recalls Carina Ventilators
08/07/2023
 
 
TXT Sage Postpartum Depression Oral Drug Approved
08/07/2023
 
 
TXT Draft Guide on Cosmetic Registration/Listing
08/07/2023
 
 
TXT Astellas Eye Drug Approved by FDA
08/07/2023
 
 
TXT FDA Clears Abbott’s Hematology Device
08/07/2023
 
 
TXT Regeneron Prostate Cancer Trial Stops Enrollment
08/04/2023
 
 
TXT FDA Floats AI Modeling to Help Assess Drug Safety
08/04/2023
 
 
TXT Nitrosamine Acceptable Intake Limits Guide
08/04/2023
 
 
TXT Mesoblast Sent Another Complete Response Letter
08/04/2023
 
 
TXT Biosense Webster New Label on Cardiac Ablators
08/04/2023
 
 
TXT FDA Floats Food-Animal Antibiotic Use Group
08/03/2023
 
 
TXT Imeka Brain White Matter Imaging Cleared
08/03/2023
 
 
TXT DSCSA Can Lead to Drug Shortages: Reps
08/03/2023
 
 
TXT DSCSA Waiver, Exception, Exemption Guidance
08/03/2023
 
 
TXT WLF Claims Win In Lexapro Case Dismissal
08/03/2023
 
 
TXT CDER into Bispecific Antibody Research, Application
08/03/2023
 
 
TXT Regeneron Responding to Eylea ‘Complete Response’
08/03/2023
 
 
TXT RenatiLabs Illegally Marketing WJMAX
08/02/2023
 
 
TXT FDA Warns Centaur on CGMP Issues
08/02/2023
 
 
TXT Advancing RWE Program Deadline Coming
08/02/2023
 
 
TXT PEPFAR Antiretroviral Drug Guidance
08/02/2023
 
 
TXT Broader Scientific Topics for Advisory Panels: Bumpus
08/02/2023
 
 
TXT Decentralized Clinical Trial Comments
08/02/2023
 
 
TXT Baxter Recalls SIGMA Infusion Pumps
08/01/2023
 
 
TXT FDA Fast Tracks Invectys IVS-3001
08/01/2023
 
 
TXT Lupin Recalls 2 Lots of Tydemy Contraceptive
08/01/2023
 
 
TXT FDA, DEA Steps to Ease Rx Stimulant Shortage
08/01/2023
 
 
TXT FDA Warns Intas About Multiple Violations
08/01/2023
 
 
TXT Iso-Tex Diagnostics CGMP Issues
08/01/2023
 
 
TXT CGMP Violations at Baxter India Facility
08/01/2023
 
 
TXT Teleflex QuikClot Device Expanded Use Cleared
08/01/2023
 
 
TXT GSK Wins Expanded Use for Jemperli
07/31/2023
 
 
TXT Senate Bill Introduced on Drug Shortages
07/31/2023
 
 
TXT FDA Expands Device TAP Pilot
07/31/2023
 
 
TXT Citius Pharma Gets Complete Response Letter
07/31/2023
 
 
TXT Abbott Withdraws Trifecta Heart Valves
07/31/2023
 
 
TXT GE Recalls TruSignal SpO2 Sensors
07/28/2023
 
 
TXT FDA, Switzerland Recognizing Each Other's Inspections
07/28/2023
 
 
TXT FDA, EMA Collaborate on Post-Approval Changes
07/28/2023
 
 
TXT FDA Not Yet Implementing OTC Drug Reforms: GAO
07/28/2023
 
 
TXT Opioid Disorder Innovative Devices
07/27/2023
 
 
TXT Compliance Woes at Wegovy Syringe Plant
07/27/2023
 
 
TXT FDA Won’t Review Toriluzole NDA
07/27/2023
 
 
TXT RFK, Jr. for FDA or CDC: DeSantis
07/27/2023
 
 
TXT Drug Shortage Legislative Fix Introduced
07/27/2023
 
 
TXT Merck Pneumococcal Vaccine Hits Phase 3 Marks
07/27/2023
 
 
TXT House Delays FDA Budget Floor Vote
07/27/2023
 
 
TXT UltraSight Ultrasound Guidance Software Cleared
07/27/2023
 
 
TXT Fentanyl Detection Kit Gains Clearance
07/26/2023
 
 
TXT Alert Update on Vessel Occlusion CADt Devices
07/26/2023
 
 
TXT Panel to Review BrainStorm ALS Submission
07/26/2023
 
 
TXT Integrating ORA in Centers Has Risks: Analysis
07/26/2023
 
 
TXT Recall Unapproved Phenobarb Products: Sun
07/26/2023
 
 
TXT Central Admixture FDA-483
07/26/2023
 
 
TXT FDA Hits Medical Device ‘Intended Use Creep’
07/26/2023
 
 
TXT Voluntary Consensus Standards Guidance
07/26/2023
 
 
TXT Abbott Recalls Amplatzer Delivery Sheath
07/26/2023
 
 
TXT Defender Pharma NDA for Scopolamine Gel
07/26/2023
 
 
TXT Beckman Coulter Chemistry Analyzer Cleared
07/25/2023
 
 
TXT Stratus Illegally Marketing Biologics: FDA
07/25/2023
 
 
TXT FDA Denies 2 Vanda Tasimelteon Petitions
07/25/2023
 
 
TXT CDRH Adds Device Sterilization Standards
07/25/2023
 
 
TXT FDA Expanding CURE ID
07/25/2023
 
 
TXT 12 Catalent Inspection Observations
07/25/2023
 
 
TXT FDA Told: ‘Generally Accepted’ Often Isn’t
07/25/2023
 
 
TXT Dismissal Sought in FDA-483 Anonymity Suit
07/25/2023
 
 
TXT 3rd Circuit Flunks FDA Again Over Illegal Generics
07/25/2023
 
 
TXT FDA Downplays Impact After Pfizer Tornado
07/24/2023
 
 
TXT ICH Mutagenic Impurities Drug Guidance
07/24/2023
 
 
TXT FDA Spending Bill Will See Veto: White House
07/24/2023
 
 
TXT Horizon Misses on Lupus Phase 2 Endpoint
07/24/2023
 
 
TXT Nesa Medtech Fibroid Mapping App Cleared
07/24/2023
 
 
TXT FDA OKs Verrica NDA for Molluscum Topical
07/24/2023
 
 
TXT ADC Therapeutics Discontinues Phase 2 Trial
07/21/2023
 
 
TXT Bufferin NDA Withdrawn by FDA
07/21/2023
 
 
TXT FDA OKs Emergent’s Anthrax Vaccine
07/21/2023
 
 
TXT Peter Stoll Guilty on Medical Device Felony Count
07/21/2023
 
 
TXT BIO Backs Rare Disease Endpoint Pilot
07/21/2023
 
 
TXT FDA Clears BD Alaris Pump Troubles
07/21/2023
 
 
TXT Wuxi Pharmaceutical FDA-483
07/20/2023
 
 
TXT Abiomed Recalls All Lots of 6 Heart Pumps
07/20/2023
 
 
TXT Vir Flu Vaccine Fails Phase 2 Trial
07/20/2023
 
 
TXT Dismiss Norwich Rifaximin Suit: FDA
07/20/2023
 
 
TXT MediView Surgical Augmented Reality Device Cleared
07/20/2023
 
 
TXT Using ctDNA as an Early Endpoint
07/20/2023
 
 
TXT FDA Monitoring Drug Shortages After Pfizer Tornado
07/20/2023
 
 
TXT FDA OKs Vanflyta for Leukemia
07/20/2023
 
 
TXT New FDA Tools in Democrats’ Preparedness Bill
07/19/2023
 
 
TXT Don’t Use Quidel Triage Cardiac Panel: FDA
07/19/2023
 
 
TXT Ex-FDA Gene Therapy Guru Joins Greenleaf
07/19/2023
 
 
TXT 8 Repeat QS Violations at Edge Biologicals
07/19/2023
 
 
TXT Ambrx Gets Fast Track for Prostate Cancer Drug
07/19/2023
 
 
TXT FDA Clears ReddyPort Ventilation Device
07/19/2023
 
 
TXT 4 Observations in SCA Pharmaceuticals FDA-483
07/19/2023
 
 
TXT Keytruda Hits Endpoint in Cervical Cancer Trial
07/19/2023
 
 
TXT FDA Clears Xstrahl Skin Cancer Radiation Therapy
07/19/2023
 
 
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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:
  • The latest agency policy developments, often before they're officially announced;
  • 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;
  • Related industry news capsules;
  • The industry's most concise FDA news index;
  • Inside-FDA news briefs
You can rely on FDA Review to provide only what's important - in the most convenient and time-saving