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FDA-RELATED NEWS
 
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TXT FDA Actions Follow Advisors 88% of Time: Analysis
07/10/2023
 
 
TXT 8 Observations on Ipca Labs FDA-483
07/10/2023
 
 
TXT CRL for Amneal Parkinson’s Drug
07/10/2023
 
 
TXT CDER Site-Selection Model MAPP
07/10/2023
 
 
TXT CDRH Moving to Electronic Export Docs
07/10/2023
 
 
TXT 29-Page Intas FDA-483
07/10/2023
 
 
TXT Outset Medical Gets Tablo Warning Letter
07/10/2023
 
 
TXT Hemogenyx CAR-T Therapy on Clinical Hold
07/10/2023
 
 
TXT VCN-01 Orphan Status for Pancreatic Cancer
06/30/2023
 
 
TXT Teleflex Recalls Endotracheal Tubes
06/30/2023
 
 
TXT House Bill on Provisional Drug Approvals
06/30/2023
 
 
TXT More Regulation Needed for Generics: Bloomberg
06/30/2023
 
 
TXT 8 Information Collections Approved by OMB
06/30/2023
 
 
TXT FDA Allows 1st Master File Use for Sterilizer
06/30/2023
 
 
TXT FDA WEBVIEW CLOSED JULY 4TH WEEK
06/30/2023
 
 
TXT Rhinosinusitis Drug Development Guidance
06/29/2023
 
 
TXT Compounding Inspection, Oversight FAQs
06/29/2023
 
 
TXT FDA OKs 1st Diabetes Cellular Therapy
06/29/2023
 
 
TXT Info Collection on Advisory Committee Regs
06/29/2023
 
 
TXT 18-Page FDA-483 on Ipca Laboratories Inspection
06/29/2023
 
 
TXT BioMarin Gene Therapy for Hemophilia A OK’d
06/29/2023
 
 
TXT Alvotech Complete Response Due to Inspection
06/29/2023
 
 
TXT 2 Roche Assays Cleared for Alzheimer’s
06/29/2023
 
 
TXT Prioritize Cancer Trial Diversity: Researchers
06/29/2023
 
 
TXT Orthopedic Implant Guide Guidance
06/28/2023
 
 
TXT Oncology Drug Approval Trends
06/28/2023
 
 
TXT CBER Updates 2023 Guidance Agenda
06/28/2023
 
 
TXT 3 GOP Senators Push FDA on Chinese Cancer Drugs
06/28/2023
 
 
TXT Comments on OPDP Quantitative Claims Research
06/28/2023
 
 
TXT FDA Reiterates NuVasive Device Indications
06/28/2023
 
 
TXT Eton Pharma Gets Complete Response Letter
06/28/2023
 
 
TXT 4 Observations in Prisma Health FDA-483
06/28/2023
 
 
TXT FDA Bars Chengdu KeCheng Drugs
06/27/2023
 
 
TXT Supply Chain Violations at Safe Chain Solutions
06/27/2023
 
 
TXT DTC Efficacy and Risk Information Guidance
06/27/2023
 
 
TXT QCARD Can Improve Oncology Submissions
06/27/2023
 
 
TXT Schumer Pushes Drug Shortage Legislation
06/27/2023
 
 
TXT Implant Sales Rep Arrested in Fraud Case
06/27/2023
 
 
TXT More ORA Changes Coming
06/27/2023
 
 
TXT FibroGen Quashes Pulmonary Fibrosis Trial
06/26/2023
 
 
TXT Draft Guide on Medical Psychedelic Drugs
06/26/2023
 
 
TXT ReShape Lifesciences sPMA for Lap-Band 2.0
06/26/2023
 
 
TXT FDA Approves Pfizer Alopecia NDA
06/26/2023
 
 
TXT UCB Psoriasis BLA Review Extended
06/26/2023
 
 
TXT CS Medical Ultrasound Probe Cleaner Cleared
06/26/2023
 
 
TXT Hold Lifted on Pharvaris Angioedema Drug
06/26/2023
 
 
TXT Pfizer Dumps Lotiglipron on Liver Injury Concerns
06/26/2023
 
 
TXT 7-Year Echo: Marks Overrode Reviewers on Duchenne Therapy
06/23/2023
 
 
TXT Draft Guide on Medical Psychedelic Drugs
06/23/2023
 
 
TXT Intercept Hit With 2nd Denial on NASH Drug
06/23/2023
 
 
TXT Jazz Pharma Sues FDA Over Competitor Approval
06/23/2023
 
 
TXT New Pathway for Breakthrough Device Coverage
06/23/2023
 
 
TXT Support In-Home Opioid Disposal: AGs
06/22/2023
 
 
TXT Rubio Questions Decision on Cisplatin Imports
06/22/2023
 
 
TXT OTC Drug Dispute Resolution Guidance
06/22/2023
 
 
TXT Arrow Recalls Peripheral Catheter System
06/22/2023
 
 
TXT Indian Drug Companies Sharing Compliance Info
06/22/2023
 
 
TXT FDA Accelerated Approval for Duchenne Gene Therapy
06/22/2023
 
 
TXT Suggestions for Pharmacogenomic Data
06/22/2023
 
 
TXT Add Plant-Based Diet Notice to Some Agonists: Petition
06/21/2023
 
 
TXT ‘Objectionable Conditions’ at Chicago Cornea
06/21/2023
 
 
TXT AZ Halts Elarekibep Asthma Phase 2a Trial
06/21/2023
 
 
TXT Complete Response Letter for Aldeyra ADX-2191
06/21/2023
 
 
TXT Anumana Gets Breakthrough on ECG-AI Algorithm
06/21/2023
 
 
TXT ChatGPT Companies Want Regulation: Califf
06/21/2023
 
 
TXT Ways to Address GSI Shortages: Report
06/21/2023
 
 
TXT Reps Urge FDA Relief on Compounded Hormones
06/21/2023
 
 
TXT FDA Cancer Biomarker Pilot
06/20/2023
 
 
TXT Multiple Violations at Vitang Technology
06/20/2023
 
 
TXT Professor Calls for Alzheimer’s Drugs REMS
06/20/2023
 
 
TXT FDA Grants, Denies BI Spiriva Petition
06/20/2023
 
 
TXT New Areas of ICH Harmonization
06/20/2023
 
 
TXT FDA Extends Neffy NDA Review
06/20/2023
 
 
TXT Surmodics Drug-Coated Balloon Approved
06/20/2023
 
 
TXT FDA Reports on State of Pharmaceutical Quality
06/20/2023
 
 
TXT Columvi Accelerated Approval for Lymphoma
06/16/2023
 
 
TXT FDA Backs Monovalent XBB.1.5 Covid Vaccine
06/16/2023
 
 
TXT Review Extended on GSK’s Momelotinib
06/16/2023
 
 
TXT Philips Safety Alert on Azurion/Allura Devices
06/16/2023
 
 
TXT FDA Posts 483 of iRhythm’s CA Facility
06/16/2023
 
 
TXT Emigality Misses Superiority in Clinical Trial
06/16/2023
 
 
TXT Reps. Introduce Drug Labeling Bill
06/15/2023
 
 
TXT Panel Backs Monovalent XBB Variant Covid Vaccine
06/15/2023
 
 
TXT AI/ML Challenges in Precision Medicine: FDA Paper
06/15/2023
 
 
TXT Corvus Wants FDA Meeting on CPI-818 Trial
06/15/2023
 
 
TXT Conditional Approval for ‘Marginal’ New Drugs: Avorn
06/15/2023
 
 
TXT FDA OKs Amendment to Uproleselan Trial
06/15/2023
 
 
TXT Public Citizen Urges FDA to Reject Duchenne BLA
06/15/2023
 
 
TXT American Lab’s Bowel Disease Assay Cleared
06/15/2023
 
 
TXT FDA Partial Hold on Mersana Trials
06/15/2023
 
 
TXT FDA to Decide Florida Drug Import by 10/31
06/14/2023
 
 
TXT Pfizer Warns of Bicillin Shortages
06/14/2023
 
 
TXT CDER Supports C-Path Pancreatic Markers
06/14/2023
 
 
TXT FDA Patient Medication Information Highlighted
06/14/2023
 
 
TXT 2seventy bio Leukemia Trial Paused
06/14/2023
 
 
TXT Starton OK’d for Multiple Myeloma Trial
06/14/2023
 
 
TXT Device Software Submission Guidance
06/13/2023
 
 
TXT A&Z Selling Illegal New Kids’ Drug
06/13/2023
 
 
TXT Recorlev Web Pages ‘False or Misleading’: FDA
06/13/2023
 
 
TXT FDA Rare Disease ARC Program Update
06/13/2023
 
 
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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