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FDA-RELATED NEWS
 
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TXT FDA Skips Foreign Inspection Hearing
02/06/2024
 
 
TXT NY Attorney General Urges FDA Action on Singulair
02/23/2024
 
 
TXT BrainStorm Seeks ‘Special Protocol” for ALS Treatment
02/23/2024
 
 
TXT Venatorx/Melinta Antibiotic Gets Complete Response
02/23/2024
 
 
TXT Bioporto Pediatric Kidney Injury Assay Cleared
02/23/2024
 
 
TXT FDA Denies Appeal; Pepaxto to be Withdrawn
02/23/2024
 
 
TXT FDA to Change Some Trial Registration Enforcement
02/22/2024
 
 
TXT Zimmer Robotic Shoulder System Cleared
02/22/2024
 
 
TXT Industry Faults FDA Research on DTC ‘Implied Claims’
02/22/2024
 
 
TXT Nearly 1,000 Generic Drugs OKd in 2023
02/22/2024
 
 
TXT Election Year Will Affect FDA Actions: Attorneys
02/22/2024
 
 
TXT Breakthrough Status for Cognitive Behavioral Therapy
02/22/2024
 
 
TXT Covid Symptoms in Clinical Trials Final Guidance
02/21/2024
 
 
TXT FDA Real-World Evidence Guide Stirs Critics
02/21/2024
 
 
TXT More Companies Should Join TAP: Shuren
02/21/2024
 
 
TXT 3 E&C Dems Urge FDA Issue Trial Diversity Guide
02/21/2024
 
 
TXT FDA Posts Medtronic Endotracheal Tube Update
02/21/2024
 
 
TXT Alert on Smartwatches Measuring Blood Glucose
02/21/2024
 
 
TXT United Therapeutics Sues FDA Over Liquidia NDA
02/21/2024
 
 
TXT Vet Third-Party Device Data: FDA
02/20/2024
 
 
TXT CBER Postmarket Requirement/Commitment SOPP
02/20/2024
 
 
TXT Steps to Address Drug and Device Shortages
02/20/2024
 
 
TXT REMS Can be Improved: Doc Survey
02/20/2024
 
 
TXT X-trodes’ Wearable Electrophysiological Monitor Cleared
02/20/2024
 
 
TXT Merck Keytruda sBLA for Endometrial Cancer
02/20/2024
 
 
TXT ARS Pharma Responding to Complete Response
02/20/2024
 
 
TXT API Manufacturing Deviations at Sichuan Deebio
02/20/2024
 
 
TXT Clinical Hold on RAPT Zelnecirnon Studies
02/20/2024
 
 
TXT Why Industry Resists FDA Quality Management Efforts
02/20/2024
 
 
TXT sBLA for Elevidys Conversion to Traditional Approval
02/16/2024
 
 
TXT Xolair Approved for Reducing Allergic Reactions
02/16/2024
 
 
TXT Gilead Sciences Pauses Magrolimab Studies
02/16/2024
 
 
TXT CDRH Product Evaluation Head Maisel Retiring
02/16/2024
 
 
TXT ANDA Product-Specific Guidances Added
02/16/2024
 
 
TXT Iovance Melanoma Cell Therapy Approved
02/16/2024
 
 
TXT Fast Track for Type 1 Diabetes Drug
02/15/2024
 
 
TXT Merit Medical’s SCOUT Surgical Guide Cleared
02/15/2024
 
 
TXT 62 New or Revised Product-Specific Guidances Out
02/15/2024
 
 
TXT Califf to News Media: Benefit the Public Health
02/15/2024
 
 
TXT Update FDA Social Media Enforcement: Durbin, Braun
02/15/2024
 
 
TXT ‘Overdose Crisis’ Gets Priority in CDER Report
02/15/2024
 
 
TXT PhRMA Seeks More FDA Info on Rare Disease Steps
02/15/2024
 
 
TXT FDA Outlines Biosimilar Educational Outreach
02/15/2024
 
 
TXT FDA Late with Diversity Plan Guidance
02/15/2024
 
 
TXT Professor Blasts FDA on Harmful Supplements
02/14/2024
 
 
TXT FDA Denies Zydus Indomethacin Suppository Petition
02/14/2024
 
 
TXT 9 Observations in Eugia Pharma Inspection
02/14/2024
 
 
TXT Citius Pharma Refiles BLA for Lymphoma
02/14/2024
 
 
TXT Smiths Medical Class 1 Recall of Syringe Pump
02/14/2024
 
 
TXT Guidance on Charging for Investigational Drugs
02/14/2024
 
 
TXT Panel Backs Abbott’s TriClip PMA
02/14/2024
 
 
TXT CDER OSI Annual Report
02/14/2024
 
 
TXT After 12+ Years, FDA Approves Steroid Label Changes
02/14/2024
 
 
TXT ‘Insanitary Conditions’ at Madhu Instruments
02/13/2024
 
 
TXT CGMP Violations in Ningbo Poplar Records
02/13/2024
 
 
TXT Information Technology Operating Plan Posted
02/13/2024
 
 
TXT FDA Approves Ipsen’s Pancreatic Cancer Drug
02/13/2024
 
 
TXT FDA Warns 2 Firms Over Illegal Weight-Loss Drugs
02/13/2024
 
 
TXT ICH Draft Guide on Post-Approval Safety Data
02/13/2024
 
 
TXT Nanox Fatty Liver Detector Cleared by FDA
02/13/2024
 
 
TXT FDA Getting Stricter on Cybersecurity Enforcement
02/13/2024
 
 
TXT Draft Guide on Advanced Manufacturing Technologies
02/12/2024
 
 
TXT FDA Panel to Discuss Abbott’s TriClip Data
02/12/2024
 
 
TXT Proscia Digital Pathology Software Cleared
02/12/2024
 
 
TXT FDA Lifts Hold on Hemogenyx CAR-T Therapy
02/12/2024
 
 
TXT FDA Issues Data Monitoring Committee Draft Guide
02/12/2024
 
 
TXT Rule on Biologic Use of Master Files
02/12/2024
 
 
TXT Orphan Status for Polycythemia Vera Drug
02/09/2024
 
 
TXT Samsung Wins De Novo for Sleep Apnea Watch, Phone
02/09/2024
 
 
TXT New Fresenius Hemodialysis Device Cleared
02/09/2024
 
 
TXT Rule on Master Files and Biologics
02/09/2024
 
 
TXT FDA/Philips Dispute on CPAP Safety Revealed: Report
02/09/2024
 
 
TXT ‘Wake Up and Do Something’: Califf on Misinformation
02/08/2024
 
 
TXT Chinese API Maker Hit with FDA-483
02/08/2024
 
 
TXT De Novo Pathway Challenges and Opportunities
02/08/2024
 
 
TXT CDER Tests Communications for Clarity
02/08/2024
 
 
TXT Philips BrightView CT System Recalled
02/08/2024
 
 
TXT Amneal Refiles NDA for Parkinson’s Drug
02/08/2024
 
 
TXT Prepare Now for QMSR Transition: Attorneys
02/07/2024
 
 
TXT Complex Generic/Hybrid Drugs Pilot Expands
02/07/2024
 
 
TXT Gilead Nixes Leukemia Phase 3 Trial
02/07/2024
 
 
TXT 6 Info Collections Approved by OMB
02/07/2024
 
 
TXT GSK Wins Priority Review for Expanded Use of RSV Vaccine
02/07/2024
 
 
TXT Califf on How FDA Addresses Chronic Diseases
02/07/2024
 
 
TXT Bipartisan Animal Testing Reform Bill
02/07/2024
 
 
TXT Breakthrough Designation for Back Pain Gel
02/07/2024
 
 
TXT Drug Manufacturing Discontinuance Guide
02/06/2024
 
 
TXT Boston Scientific’s Spinal Cord Stimulator Wins 50% Pain Cut OK
02/06/2024
 
 
TXT FDA Again Cites Catalent Facility
02/06/2024
 
 
TXT Les Importations Herbasanté CGMP Issues
02/06/2024
 
 
TXT Think Like a Consumer on DTC Ads: Attorneys
02/06/2024
 
 
TXT CGMP Issues in Nantong Furuida Records Review
02/06/2024
 
 
TXT Vanda sNDA Hetlioz Review Hits Snag: FDA
02/06/2024
 
 
TXT 3 Ways Congress Can Cut Drug Shortages: Duke-Margolis
02/06/2024
 
 
TXT Cardinal Health Recalls Urology/Operating Trays
02/05/2024
 
 
TXT Vertex Plans Mid-year Cystic Fibrosis NDA
02/05/2024
 
 
TXT Centera, CEO Sentenced Over Unapproved Drugs
02/05/2024
 
 
TXT J&J Reports Positive Data on Nipocalimab
02/05/2024
 
 
TXT Guidance on Reporting Listed Drug Amounts
02/05/2024
 
 
TXT Glaucoma Pressure Reducer Goes to Panel
02/05/2024
 
 
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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