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  10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 Next >>
 
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 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 Columvi Accelerated Approval for Lymphoma
06/16/2023
 
 
TXT FDA Backs Monovalent XBB.1.5 Covid Vaccine
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
 
 
TXT OTC Erectile Dysfunction Gel Authorized in U.S.
06/13/2023
 
 
TXT BIO on FDA Data, Technology Plan
06/13/2023
 
 
TXT More Data Needed for Neffy ANDA: Viatris
06/13/2023
 
 
TXT Wearable Smart Thermometer Recalled
06/12/2023
 
 
TXT Phathom Pharma Resubmits Vonoprazan NDA
06/12/2023
 
 
TXT FDA Backs New Covid Vaccine with XBB Variant
06/12/2023
 
 
TXT Info Collection on MedSun Device Reporting
06/12/2023
 
 
TXT Collection on Device Premarket Notification Revised
06/12/2023
 
 
TXT MAPP on ANDA Facility Deficiency Reclassifiaction
06/12/2023
 
 
TXT Linzess Approved for Pediatric Constipation
06/12/2023
 
 
TXT FDA Needs New Policies for AI: Gottlieb
06/09/2023
 
 
TXT FDA Alert on Oxygenator Recall
06/09/2023
 
 
TXT Panel Backs Full Approval of Alzheimer’s Drug
06/09/2023
 
 
TXT SurGenTec Sacroiliac Joint Fusion Device Cleared
06/09/2023
 
 
TXT Bipartisan Bill on Provisional FDA Approvals
06/09/2023
 
 
TXT FDA Sees Need to Better Address Drug Shortages
06/08/2023
 
 
TXT Oral Contraceptive Drug Interaction Guidance
06/08/2023
 
 
TXT Avita Skin Defect Device Get Expanded Use
06/08/2023
 
 
TXT FDA Taps Murphy to Head Generic Drugs Office
06/08/2023
 
 
TXT Panel Backs RSV Monoclonal Antibody
06/08/2023
 
 
TXT Create One PPI Guidance for all Products: Novartis
06/08/2023
 
 
TXT Assessing GDUFA User Fees Guidance
06/08/2023
 
 
TXT FDA Ups Pediatric Exclusivity Requirements: Attorneys
06/08/2023
 
 
TXT CBER Post-Covid Transition Information
06/07/2023
 
 
TXT Eisai/Biogen Alzheimer’s Drug Effective: FDA
06/07/2023
 
 
TXT Bioresearch Monitoring Issues in Mazhar Trials
06/07/2023
 
 
TXT PMI ‘Major Change’ in Drug Labeling: Attorneys
06/07/2023
 
 
TXT FibroGen’s Pamrevlumab Fails Phase 3
06/07/2023
 
 
TXT AdvaMed Recommendations for Patient Preference
06/07/2023
 
 
TXT Adderall Shortage Process “Muddy, Obscure”: Wyden
06/06/2023
 
 
TXT Updated ICH Good Clinical Practice Guidance
06/06/2023
 
 
TXT Multiple Violations at Steiner Biotechnology
06/06/2023
 
 
TXT iRhythm Technologies Cited for Unapproved Device
06/06/2023
 
 
TXT Norwich Sues FDA Over Rifaximin ANDA
06/06/2023
 
 
TXT FDAers Assess Frontline Renal Cancer Treatments
06/06/2023
 
 
TXT Sun Pharma India Facility on Import Alert
06/06/2023
 
 
TXT FDA Struggles to Recruit in Wake of Retirements
06/06/2023
 
 
TXT Abiomed Recalls Impella Heart Pump
06/05/2023
 
 
TXT FDA on Pneumatic Tourniquet Cuff Shortage
06/05/2023
 
 
TXT FDA Lifts Hold on Foghorn Leukemia Drug
06/05/2023
 
 
TXT Draeger Recalls Ventilator Sets/Tubing
06/05/2023
 
 
TXT Intas Pharma on Import Alert After Inspection
06/05/2023
 
 
TXT Guidance on ANDA Cover Letter Attachments
06/05/2023
 
 
TXT FDA Lifts Hold on Multiple Myeloma Drug
06/02/2023
 
 
TXT Durbin Urges FDA to Act More on Cancer Drug Shortage
06/02/2023
 
 
TXT Therapeutic Protein Drug Interaction Assessment Guide
06/02/2023
 
 
TXT Guidance on Device Pre-Submission Meetings
06/02/2023
 
 
TXT Interstitial Cystitis/Bladder Pain Syndrome Guidance
06/02/2023
 
 
TXT FDA Withdraws 8 No-Longer-Marketed ANDAs
06/01/2023
 
 
TXT FDA OKs Pfizer Abrysvo RSV Vaccine
06/01/2023
 
 
TXT Migraine Drug Development Guidance
06/01/2023
 
 
TXT AstraZeneca Ends Brazikumab Development
06/01/2023
 
 
TXT Balance AI Optimism and Pessimism: Califf
06/01/2023
 
 
TXT Roche/Genentech Suggestions for nAMD Guidance
06/01/2023
 
 
TXT Patient Access to At-Home Technologies
06/01/2023
 
 
TXT Doc Bought Oncology Meds to Sell for Profit: DoJ
06/01/2023
 
 
TXT FDA Clears Ezra Flash AI for MRI Quality
06/01/2023
 
 
TXT CDER Drug Policy Guru Heads to Morgan Lewis
06/01/2023
 
 
TXT Clinical Hold on PepGen IND Application
05/31/2023
 
 
TXT Precision BioSciences to Meet with FDA on Azer-Cel
05/31/2023
 
 
TXT Groups Want Regulation of Lab-Developed Tests
05/31/2023
 
 
TXT Junshi Bio Inspection to Advance Toripalimab BLA
05/31/2023
 
 
TXT FDA to Permit In-Person End-of-Phase 2 Meetings
05/31/2023
 
 
TXT FDA Alert on Compounded Semaglutide
05/31/2023
 
 
TXT CDER Risk, Safety Report for 2022 Issued
05/31/2023
 
 
TXT FDA Limited in Managing Drug Shortages: Pazdur
05/31/2023
 
 
TXT FDA Proposes 1-Page Patient Medication Information
05/30/2023
 
 
TXT Violations at Advanced Compounding Solutions
05/30/2023
 
 
TXT Priority Review for BMS Lung Cancer Drug
05/30/2023
 
 
TXT Concerns with Macular Degeneration Guidance
05/30/2023
 
 
TXT Janssen NDA for Pulmonary Hypertension Drug
05/30/2023
 
 
<< Prev  10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29  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