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FDA-RELATED NEWS
 
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TXT Senators Introduce Bill to Reduce Animal Testing
09/13/2024
 
 
TXT Feedback Sought on Integrated Review Document
09/12/2024
 
 
TXT FDA Publishes 8th Revision of Electronic Format Guide
09/12/2024
 
 
TXT Apple AirPods Hearing Software Authorized
09/12/2024
 
 
TXT Tremfya Secures Approval for Ulcerative Colitis
09/12/2024
 
 
TXT Gilead Positive on Twice-Yearly HIV Drug Data
09/12/2024
 
 
TXT GSK Moves mRNA Flu Vaccine to Phase 3
09/12/2024
 
 
TXT FDA Veozah Liver Injury Warning
09/12/2024
 
 
TXT Recommendations on Rare Disease Collaboration
09/12/2024
 
 
TXT CDER Quantitative Medicine CoE Explained
09/11/2024
 
 
TXT GDUFA ANDA Amendment Submissions
09/11/2024
 
 
TXT OPDP Hits AbbVie Over Serena Williams DTC Ad
09/11/2024
 
 
TXT 3 FDA Innovative Manufacturing Action Steps
09/11/2024
 
 
TXT FDA Warns 2 Chinese Labs About Data Concerns
09/11/2024
 
 
TXT Lawsuit Against FDA Dismissed on Ripeness Grounds
09/11/2024
 
 
TXT Ocaliva Confirmatory Trial Fails: FDA
09/11/2024
 
 
TXT CGMP Violations at Zydus Lifesciences Facility
09/10/2024
 
 
TXT Multiple Optikem International Violations Cited
09/10/2024
 
 
TXT Changes Sought in FDA Misinformation Guidance
09/10/2024
 
 
TXT FDA Clears Sonic Incytes’ Velacur Device
09/10/2024
 
 
TXT FDA Mulls More Post-Inspection Feedback: Cavazzoni
09/10/2024
 
 
TXT Follow FDA Online Misinformation Guidance: Attorneys
09/10/2024
 
 
TXT DeepWell Digital Software Cleared for Stress Relief
09/10/2024
 
 
TXT GSK Highlights Depemokimab Asthma Data
09/09/2024
 
 
TXT Hold Removed on Rezolute Hypoglycemia Drug
09/09/2024
 
 
TXT Femasys Fallopian Tube Diagnostic Cleared
09/09/2024
 
 
TXT Lab Group Seeks Congress’ Help on LDT Rule
09/09/2024
 
 
TXT CBER Updates Refusal-to-File Procedure
09/09/2024
 
 
TXT Travere’s Filspari Converted to Full Approval
09/06/2024
 
 
TXT Panel to Review Stealth Bio Barth Syndrome NDA
09/06/2024
 
 
TXT GSK Reports Trial Results of Nucala in COPD
09/06/2024
 
 
TXT Odin Medical AI Colon Polyp Detector
09/06/2024
 
 
TXT Eye Product Manufacturer Hit with Warning Letter
09/06/2024
 
 
TXT Biocon Biologics Gets 10-item FDA-483
09/06/2024
 
 
TXT Patient Preference Info in Product Life Cycle
09/05/2024
 
 
TXT Medtronic Laryngoscope Recall is Class 1
09/05/2024
 
 
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
 
 
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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
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