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FDA-RELATED NEWS
 
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TXT Priority Review for Servier’s Tibsovo sNDA
08/16/2023
 
 
TXT Abortion Drug Can Remain on Market: Appeals Court
08/16/2023
 
 
TXT FDA’s Lighter Enforcement May be Ending: Attorney
08/16/2023
 
 
TXT New FDA PathologAI Initiative
08/16/2023
 
 
TXT Deficiencies in CM and RTRT-D NDA Submissions
08/16/2023
 
 
TXT Multiple Denison Pharmaceuticals Violations
08/16/2023
 
 
TXT CDRH Prefers Guidance Comments in Table Format
08/16/2023
 
 
TXT AstraZeneca Gets 1st OPDP 2023 Warning Letter
08/15/2023
 
 
TXT Informed Consent Guidance
08/15/2023
 
 
TXT QS Violations at TEI Biosciences
08/15/2023
 
 
TXT Hold Lifted on Arcellx Myeloma Drug
08/15/2023
 
 
TXT Info Collection Revision on BLA Procedures
08/15/2023
 
 
TXT FDA Denies St. Jude Codeine Use Petition
08/15/2023
 
 
TXT More Supplements Risk Oversight Coming: Califf
08/15/2023
 
 
TXT Breakthrough Status for AngioVac System
08/15/2023
 
 
TXT Florida Amends FOIA Lawsuit Against FDA
08/14/2023
 
 
TXT Clinical Hold on AML Cell Therapy
08/14/2023
 
 
TXT FDA Extends Review of Chikungunya Vaccine
08/14/2023
 
 
TXT Phillips Recalls Trilogy EVO Ventilators
08/14/2023
 
 
TXT Biocon Malaysia Plant Hit with 8-item 483
08/14/2023
 
 
TXT Guide on Off-the-Shelf Software in Devices
08/11/2023
 
 
TXT Astellas sNDA Filed for Pediatric Cresemba
08/11/2023
 
 
TXT Ceribell’s ClarityPro For Detecting Seizures
08/11/2023
 
 
TXT FDA Warning on 15 Universal Meditech Tests
08/11/2023
 
 
TXT FDA On Parametric Release for Sterile Drugs
08/11/2023
 
 
TXT Data on Under-Represented Patients Guide
08/11/2023
 
 
TXT PAS Classification Category Guidance
08/10/2023
 
 
TXT FDA Approves Janssen’s Talvey
08/10/2023
 
 
TXT Underrepresented Population Data Guidance
08/10/2023
 
 
TXT FDA Updates Regulatory Science Device Catalog
08/10/2023
 
 
TXT Cardiosave Intra-aortic Balloon Pumps Recalled
08/10/2023
 
 
TXT PhRMA, Others Boost FDA Discussion Paper on AI
08/10/2023
 
 
TXT Guide on QTc Labeling Information
08/09/2023
 
 
TXT FDA OKs Aspen IND for Parkinson’s Therapy
08/09/2023
 
 
TXT FDA to Review Vitaris/Mapi GA Depot NDA
08/09/2023
 
 
TXT Doctors, Health Systems Should Test Generics: Article
08/09/2023
 
 
TXT Law Settles ‘Active Ingredient’ Debate
08/09/2023
 
 
TXT 5 Pharmas Settle Improper Reimbursement Case
08/09/2023
 
 
TXT FDA Grants Traditional Approval to Gavreto
08/09/2023
 
 
TXT Galera Gets ‘Complete Response’ on Mucositis Drug
08/09/2023
 
 
TXT Curiteva Navigation Instruments for Fusion Cleared
08/08/2023
 
 
TXT ‘Less Rigorous Standards’ in Drug Approvals: Study
08/08/2023
 
 
TXT FDA Modernizing GCP Guidelines: Attorneys
08/08/2023
 
 
TXT FDA Warns Overseas OTC Manufacturers
08/08/2023
 
 
TXT CBER Allowing Device ‘In-Person’ Meetings
08/08/2023
 
 
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
 
 
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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