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
 
<< Prev  1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>
 
TXT Glenmark Pays $25 Million in False Claims Case
09/05/2024
 
 
TXT Breas Medical Recalls Vivo 45 LS Ventilators
09/05/2024
 
 
TXT Lilly Reports Positive Data in Weekly Insulin Trials
09/05/2024
 
 
TXT FDA ‘Overdue’ on 2,000 Drug Plant Inspections: AP
09/05/2024
 
 
TXT Committee to Consider Iterum Sulopenem NDA
09/05/2024
 
 
TXT Group Seeks Clarity on Use-Related Risk Analyses
09/05/2024
 
 
TXT Drug Nitrosamine Impurity Control Guidance
09/04/2024
 
 
TXT Baxter Recalls Volara Circuits, Adapter
09/04/2024
 
 
TXT Comments on ICH RWD Studies Guidance
09/04/2024
 
 
TXT Labs Ask Court to Throw Out FDA’s LDT Rule
09/04/2024
 
 
TXT SoloVital Illegally Marketing Hyaluronic Acid: FDA
09/04/2024
 
 
TXT California Man Pleads Guilty to Illegal Etizolam Sales
09/04/2024
 
 
TXT Vanda Sues FDA Over Pending Tradipitant NDA Decision
09/04/2024
 
 
TXT Atlanta Doctor’s Research Didn’t Follow Plan: FDA
09/03/2024
 
 
TXT Company Illegally Marketing ‘Stem Cells’: FDA
09/03/2024
 
 
TXT PhRMA Wants Changes to Platform Tech Designation
09/03/2024
 
 
TXT Correct ‘Misleading’ AbbVie Study Description: Ali
09/03/2024
 
 
TXT Many Ideas to Approve FDA Regulation of AI: Article
09/03/2024
 
 
TXT FDA Study Analyzes Provider View of Boxed Warnings
09/03/2024
 
 
TXT Guidance on BIMO Data Technical Specifications
09/03/2024
 
 
TXT Otsuka Pharmaceutical FDA-483 Released
09/03/2024
 
 
TXT FDA Clears Embecta Disposable Insulin Patch Pump
09/03/2024
 
 
TXT ADHD Digital Therapy Devices Put Into Class 2
08/30/2024
 
 
TXT Feedback Sought on Model-Informed Drug Development
08/30/2024
 
 
TXT FDA Authorizes Updated Novavax Covid Vaccine
08/30/2024
 
 
TXT Emergent Bio Wins Mpox Vaccine Approval
08/30/2024
 
 
TXT Device Malfunction Summary Reporting Guide
08/29/2024
 
 
TXT J&J Files BLA for Myasthenia Gravis Therapy
08/29/2024
 
 
TXT FDA Publishes 2 Revised VICH Guidances
08/29/2024
 
 
TXT Merck Discontinues 2 Keytruda Phase 3 Trials
08/29/2024
 
 
TXT Tandem Updates Apple Mobile Diabetes Pump App
08/29/2024
 
 
TXT CDER Creates Internal AI Council
08/29/2024
 
 
TXT Renata Expandable Growth Stent OK’d for Infants
08/29/2024
 
 
TXT Exela’s Fentanyl Not Withdraw Over Safety/Efficacy
08/28/2024
 
 
TXT Leqvio Successfully Lowers LDL-C: Study
08/28/2024
 
 
TXT FDA Warns Companies on Unapproved CPAP Cleaners
08/28/2024
 
 
TXT SpringWorks Therapeutics NDA Accepted by FDA
08/28/2024
 
 
TXT Liveyon Founder Pleads Guilty
08/28/2024
 
 
TXT Malfunction Reporting Program Guidance
08/28/2024
 
 
TXT Require More Breakthrough Postmarket Studies: Research
08/28/2024
 
 
TXT Abbott Class 1 Recall of FreeStyle Libre Sensors
08/28/2024
 
 
TXT Global Calcium India Facility Hit with FDA-483
08/28/2024
 
 
TXT 5 CGMP Observations in CARsgen Inspection
08/27/2024
 
 
TXT EyePoint Pharmaceuticals GCMP Violations
08/27/2024
 
 
TXT Illumina’s TrusSight Test OK'd as Companion Diagnostic
08/27/2024
 
 
TXT FDA Tightens Pemgarda Covid-19 EUA
08/27/2024
 
 
TXT FDA Expanding RWD/RWE Use: Marston
08/27/2024
 
 
TXT Ractigen Gets Orphan Status for Duchenne’s
08/27/2024
 
 
TXT Amgen’s Blincyto Gets Expanded Approval
08/27/2024
 
 
TXT Change Platform Technology Guidance: Stakeholders
08/27/2024
 
 
TXT BeiGene Gets Fast Track on Leukemia Therapy
08/26/2024
 
 
TXT Omnipod 5 Expanded Clearance for Type 2 Diabetes
08/26/2024
 
 
TXT Half of AI Devices Lack Clinical Validation Data: Research
08/26/2024
 
 
TXT iRhythm Hit With 2nd FDA-483 in a Month
08/26/2024
 
 
TXT Rhythm Files for Imcivree Expanded Use
08/26/2024
 
 
TXT Public Citizen Calls for Shuren Probe by OIG
08/23/2024
 
 
TXT Biologic Manufacturing Quality Deteriorating: Cavazzoni
08/23/2024
 
 
TXT SurGenTech Bone Marrow Aspirate Kit Cleared
08/23/2024
 
 
TXT Class 1 Recall of ClotTriever XL
08/23/2024
 
 
TXT De Novo Electronic Submission Template
08/22/2024
 
 
TXT Bumpus Refuses to Approve Intarcia NDA
08/22/2024
 
 
TXT Panel to Mull Stomach/Esophagus Cancer Therapies
08/22/2024
 
 
TXT Guide on Device Change Control Plans
08/22/2024
 
 
TXT FDA OKs Updated Covid Vaccines
08/22/2024
 
 
TXT Defibtech Recalls Chest Compression Device
08/22/2024
 
 
TXT FDA Publishes 68 New, Revised Product-Specific Guides
08/22/2024
 
 
TXT Request for Information Guidance
08/22/2024
 
 
TXT Liquidia Sues FDA Over Tyvaso’s Exclusivity
08/22/2024
 
 
TXT Exposé Hits Ethics Conflicts in Shuren’s Job and Wife’s Industry Roles
08/21/2024
 
 
TXT Medical Device PCCP Guidance
08/21/2024
 
 
TXT PhRMA Seeks Changes in Bio Interchangeability Guidance
08/21/2024
 
 
TXT 3rd Party Inspection Findings Hits Regeneron BLA
08/21/2024
 
 
TXT ICH Pediatric Extrapolation Guidance
08/21/2024
 
 
TXT Over 1,000 BIMO Inspections in FY 2023
08/21/2024
 
 
TXT Novartis Wins Generic Entresto Approval Stay
08/21/2024
 
 
TXT FTC Supports FDA Draft on Interchangeable Biosimilars
08/20/2024
 
 
TXT GAO Sees Actions, Challenges in Device Surveillance
08/20/2024
 
 
TXT Reps Seek FDA Action on Drug Research in China
08/20/2024
 
 
TXT Significant CGMP Violations at Eugia Pharma
08/20/2024
 
 
TXT LDT ‘Power Grab’ Suit Filed Against FDA
08/20/2024
 
 
TXT Lilly’s Tirzepatide Curbs Progression to Diabetes
08/20/2024
 
 
TXT Post Timely De Novo Summaries: Law Firm
08/20/2024
 
 
TXT ICU Medical Expands Class 1 Recall of Infusion Pumps
08/20/2024
 
 
TXT Pennsaid Not Withdrawn Due to Safety/Efficacy
08/20/2024
 
 
TXT J&J Combo Approved for Lung Cancer
08/20/2024
 
 
TXT Enhertu Given Breakthrough Status in Breast Cancer
08/19/2024
 
 
TXT Hold Lifted on Lung/Breast Cancer ADC Drug
08/19/2024
 
 
TXT SoClean CPAP Disinfecting Device Authorized
08/19/2024
 
 
TXT Guide on ANDA Meeting Requests
08/19/2024
 
 
TXT FDA Denies Petition Seeking to Block Liquidia NDA
08/19/2024
 
 
TXT At-Home Test Authorized for Syphilis
08/16/2024
 
 
TXT iRhythm Hit with 483 After July Inspection
08/16/2024
 
 
TXT HHS Assists FDA with BD’s Bactec Shortage
08/16/2024
 
 
TXT Imfinzi OK’d for Resectable Lung Cancer
08/16/2024
 
 
TXT Court Nixes Restraining Order Request in Entresto Suit
08/16/2024
 
 
TXT FDA Pushed to Regulate Online Drug Promos
08/15/2024
 
 
TXT No-Longer-Marketed Entereg’s Approval Withdrawn
08/15/2024
 
 
TXT FDA Debars Ryan Stabile for 15 Years
08/15/2024
 
 
TXT More FDA ‘Stringency’ Seen on Accelerated Drug OKs
08/15/2024
 
 
TXT FDA Clears Cresilon’s Traumagel
08/15/2024
 
 
<< Prev  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