FDA Webview Site FDA Review Site FDA Updater Site
header.gif
Username:
Password:
 

human drugs
animal drugs
biologics
eirs 483s
medical devices
marketing
email
search our site
  
FDA-RELATED NEWS
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>
 
TXT Hill Staffer Graham Appointed to FDA Policy Office
04/16/2025
 
 
TXT Celltrion’s Humira Biosimilar Now Interchangeable: FDA
04/16/2025
 
 
TXT Marks’ Firing Challenges RFK Jr.’s Fitness for Office
03/31/2025
 
 
TXT DOGE-Targeted FDA Lab to Remain Open
03/05/2025
 
 
TXT QS Violations at Noah Medical Corporation
04/22/2025
 
 
TXT Promising Enhertu+Perjeta Data in Breast Cancer
04/22/2025
 
 
TXT Lt. Governors Urge Trump to Support FDA, Other Agencies
04/22/2025
 
 
TXT ICU Medical Illegally Marketing Devices: FDA
04/22/2025
 
 
TXT CDER Continues Quality Management Program
04/22/2025
 
 
TXT FDA Integrity, Decision-Making at Risk: Blog
04/22/2025
 
 
TXT ICH Q1 Stability Testing Guide Out for Comment
04/22/2025
 
 
TXT FDA Alert on Compounded Topical Finasteride
04/22/2025
 
 
TXT Drug Promotion Leaders Leave Agency
04/22/2025
 
 
TXT FDA Inspections Will Suffer Under FDA Cuts: Lawyers
04/21/2025
 
 
TXT Bard Recalls BD 4 Fr. PowerPICC Catheters
04/21/2025
 
 
TXT Rare Disease Drug Development Articles
04/21/2025
 
 
TXT Makary Says FDA Exploring Conditional Approvals
04/21/2025
 
 
TXT Leaked Budget Document Projects FDA Cuts: Report
04/21/2025
 
 
TXT Urgent Steps to Counter Need for Chinese Drugs: Exiger
04/21/2025
 
 
TXT FDA Restricting Industry Reps on Advisory Committees
04/21/2025
 
 
TXT Trump to FDA: Boost Generics, OTCs, Rx Imports
04/16/2025
 
 
TXT AI in Regulatory Science: Conference Report
04/16/2025
 
 
TXT Digital Health Technologies an FDA Priority: Article
04/16/2025
 
 
TXT Inspections Will Suffer Under FDA Cuts: Lawyers
04/16/2025
 
 
TXT FDA Wants Contractors to Replace Some Fired Staff
04/16/2025
 
 
TXT 2 Medical Device FAQs Issued
04/16/2025
 
 
TXT Naturista Store Markets Unapproved Drug: FDA
04/15/2025
 
 
TXT CGMP Issues Found in PMS4PMS Inspection
04/15/2025
 
 
TXT FDA Clears eGenesis Perfusion Trial
04/15/2025
 
 
TXT Mural Oncology Scraps Nemvaleukin Alfa
04/15/2025
 
 
TXT FDA Authorizes Click’s Migraine Digital Therapeutic
04/15/2025
 
 
TXT China Stricter than U.S. in Cancer Drug Approvals: Study
04/15/2025
 
 
TXT Address Heart Failure Patient-Reported Outcome Issues
04/15/2025
 
 
TXT Recall All Humacyte Symvess Products: Petition
04/15/2025
 
 
TXT TEST
04/14/2025
 
 
TXT FDA Clears Bright Uro’s Urodynamics Device
04/14/2025
 
 
TXT Ironwood Needs Another Apraglutide Trial: FDA
04/14/2025
 
 
TXT Pfizer Nixes Oral Weight Loss Drug Development
04/14/2025
 
 
TXT FDA Seizes Counterfeit Ozempic in Supply Chain
04/14/2025
 
 
TXT Vanda Sues FDA to Allow Off-Label Promotion
04/14/2025
 
 
TXT Marks Warns of Growing Anti-Vaccine Stance
04/11/2025
 
 
TXT Self-Inject Vyvgart Hytrulo Approved
04/11/2025
 
 
TXT FDA OKs Opdivo + Yervoy in Liver Cancer
04/11/2025
 
 
TXT Sen. Paul Introduces Biosimilars Bill
04/11/2025
 
 
TXT RFK Jr. Misfires at FDA Headquarters Address
04/11/2025
 
 
TXT Daxor Files 510(k) for Next-Gen Blood Analyzer
04/11/2025
 
 
TXT Bipartisan Brain Cancer Research Bill In
04/10/2025
 
 
TXT FDA to Phase Out Some Drug Animal Testing
04/10/2025
 
 
TXT Biomedical Industry Seeks Senate Help on FDA Cuts
04/10/2025
 
 
TXT ‘Information Bottleneck’ Due to FDA Staff Cuts: Analysis
04/10/2025
 
 
TXT FDA to Allow Some Teleworking: AP
04/10/2025
 
 
TXT FDA Clears Dexcom Glucose Monitor
04/10/2025
 
 
TXT FDA Clears Intuitive Stapler for da Vinci Robot
04/10/2025
 
 
TXT Support, Suggestions for FDA Regulatory AI Guidance
04/09/2025
 
 
TXT Generic Policy Shop Cuts will Hurt ANDAs: Post
04/09/2025
 
 
TXT Coordinate HHS Drug Shortage Activities: GAO
04/09/2025
 
 
TXT FDA OKs Dropping Tryvio REMS
04/09/2025
 
 
TXT Raskin, Others Seek FDA Meeting on Cuts
04/09/2025
 
 
TXT Kessler Slams Dangerous FDA Cuts at Hearing
04/09/2025
 
 
TXT Device Approvals Slow to 10-Year Low: Report
04/09/2025
 
 
TXT User Fee Programs are in Jeopardy: FDA Watchers
04/08/2025
 
 
TXT Restrict 2 Opioid Indications: Petition
04/08/2025
 
 
TXT ZyVersa Touts Approval Path for Kidney Disorder Drug
04/08/2025
 
 
TXT FDA ‘Like Flat Earthers Taking Over NASA’: Woodcock
04/08/2025
 
 
TXT FDA OKs Opdivo/Yervoy in Colon Cancer
04/08/2025
 
 
TXT Multiple Violations at EpiCare Acquisitions
04/08/2025
 
 
TXT Laboratory-Developed Test Decision Reviewed
04/08/2025
 
 
TXT Allogene Gets 3 Fast Tracks for Cell Therapy
04/07/2025
 
 
TXT Kennedy Senate Hearing Postponed
04/07/2025
 
 
TXT Teva Files sBLA to Expand Migraine Therapy’s Use
04/07/2025
 
 
TXT Device Reviews Will Now Take Longer: Shuren
04/07/2025
 
 
TXT Amgen’s Uplizna OK’d for Immunoglobulin G4 Disease
04/04/2025
 
 
TXT Could HHS Mea Culpa Lead to FDA Rehires?
04/04/2025
 
 
TXT House Committee Hearing on Reducing FDA Inefficiencies
04/04/2025
 
 
TXT Marks: RFK Jr. Wants FDA to Support Stem-cell Treatments
04/04/2025
 
 
TXT Draeger Recalls Flex 220 Breathing Circuit
04/04/2025
 
 
TXT CRL for Aldeyra’s Reproxalap for Dry Eye
04/03/2025
 
 
TXT Reorganization Will Block Information Flow
04/03/2025
 
 
TXT Makary Will Face Political Interference Soon: Gottlieb
04/03/2025
 
 
TXT BeiGene Drops Ociperlimab Development in Lung Cancer
04/03/2025
 
 
TXT Accelerated Approval Faces Scrutiny After Cancer Drug Review
04/03/2025
 
 
TXT Biogen Gets Fast Track for Alzheimer’s Therapy
04/02/2025
 
 
TXT Can FDA “Do More With Less?”: McClellan
04/02/2025
 
 
TXT Industry Sounds the Alarm on FDA Staff Cuts
04/02/2025
 
 
TXT Ocrevus IV Phase 3 Study Misses Primary Endpoint
04/02/2025
 
 
TXT Positive EDG-7500 Heart Drug Phase 2 Results
04/02/2025
 
 
TXT RFK Jr. Invited to Senate Hearing on HHS Reorganization
04/02/2025
 
 
TXT FDA Misses Novavax Covid Vaccine Review Action
04/02/2025
 
 
TXT FDA Remaking Inspection Priorities in Wake of Trump Cuts
04/02/2025
 
 
TXT FDA Says Rex Implants Illegally Marketing Devices
04/01/2025
 
 
TXT Bausch + Lomb Recalls enVista Intraocular Lenses
04/01/2025
 
 
TXT Axsome Solriamfetol Misses Primary Endpoint
04/01/2025
 
 
TXT 3 Observations on SKNV Outsourcing FDA-483
04/01/2025
 
 
TXT Multiple Violations in Next Science Inspection
04/01/2025
 
 
TXT FDA in Upheaval as Staff Layoffs Begin
04/01/2025
 
 
TXT RFK Jr. Upends His Promise to Enhance Transparency
04/01/2025
 
 
TXT Vanda Files NDA for Antipsychotic Drug
03/31/2025
 
 
TXT Trump Order Stifles Union Representation at FDA
03/31/2025
 
 
TXT Merck Touts Data in Pulmonary Arterial Hypertension
03/31/2025
 
 
TXT FDA Loses on Regulating Lab-Developed Tests
03/31/2025
 
 
  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>
 
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