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FDA-RELATED NEWS
 
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TXT REMS Document Format, Content Guidance
01/04/2023
 
 
TXT Arrow Intra-Aortic Balloon Pump Recall is Class 1
01/04/2023
 
 
TXT Latest Potential Signals of Serious Drug Risks
01/04/2023
 
 
TXT Drug Companies Expected to Hike Prices
01/04/2023
 
 
TXT Vivos Gets Sleep Apnea Device Cleared
01/04/2023
 
 
TXT Consider Oncology Single-Arm Trial Issues: CDER
01/04/2023
 
 
TXT FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study
01/04/2023
 
 
TXT Advanced Bionics Paying $12 Million Over False Claims
01/03/2023
 
 
TXT CGMP Deviations at Brazil’s Nortec Quimica
01/03/2023
 
 
TXT FDA States Plan B One-Step Does Not Cause an Abortion
01/03/2023
 
 
TXT Court Enters Consent Decree Against Oklahoma Compounder
01/03/2023
 
 
TXT M11 Clinical Electronic Structured Protocol
01/03/2023
 
 
TXT Drug Risks and Benefits in CSL Communications
01/03/2023
 
 
TXT ‘Objectionable Conditions’ at Clinical Investigation Site
01/03/2023
 
 
TXT Spending Bill Reverses Some FDA Court Losses: Attorneys
01/03/2023
 
 
TXT FDA Pushing Naloxone OTC Switch: Attorney
01/03/2023
 
 
TXT Hypertension Labeling for Cardio Claims Guidance
01/03/2023
 
 
TXT FDA Gets $226 Million Spending Boost in Budget Bill
01/03/2023
 
 
TXT FDA Grants Ardelyx’ Xphozah Appeal
01/03/2023
 
 
TXT FDA Discusses 2 New Trilogy Ventilator Issues
01/03/2023
 
 
TXT FDA Needs More Global Help Against Crime: Hermsen
01/03/2023
 
 
TXT Reactions to Aduhelm Report Blast FDA Closeness to Industry
01/03/2023
 
 
TXT Providence Medical Tech Cavux Facet Device Cleared
12/16/2022
 
 
TXT FDA OK’s Ferring’s Bladder Cancer Gene Therapy
12/16/2022
 
 
TXT Panel to Examine Ongoing Covid Vaccine Modifications
12/16/2022
 
 
TXT Contractor Conflict-of Interest Bill Passes Congress
12/16/2022
 
 
TXT Aurigene Ditches Psoriasis Drug Candidate
12/16/2022
 
 
TXT FDA Updates CRL Guidance Performance Goals
12/15/2022
 
 
TXT Comments on Immune-Mediated Adverse Reaction Guidance
12/15/2022
 
 
TXT Independent FDA Needed to Stop Political Meddling: GAO
12/15/2022
 
 
TXT Draft Guide on Pulmonary Tuberculosis Drugs
12/15/2022
 
 
TXT Draft Inspection Refusal Guidance
12/15/2022
 
 
TXT FDA Stem Cell Therapy Regulation at Risk: Attorneys
12/15/2022
 
 
TXT States Pushing for Canadian Drug Imports: Report
12/14/2022
 
 
TXT Harmonize Innovative Manufacturing Regulation: PhRMA
12/14/2022
 
 
TXT AdvaMed Supports Breakthrough Device Guidance Updates
12/14/2022
 
 
TXT VALID Could Hurt Home Sample Testing: Attorneys
12/14/2022
 
 
TXT Former NECC Ops Director Sentenced to 5 Months in Jail
12/14/2022
 
 
TXT FDA Panel Thumbs Down on Heart Failure Drug
12/14/2022
 
 
TXT FDA Accepts NDA for Eye Dilating Combo Product
12/13/2022
 
 
TXT $2.25 mil. RWD Funding Opportunity
12/13/2022
 
 
TXT CGMP Deviations Seen in Centrient Inspection
12/13/2022
 
 
TXT Clinicians Need Refresher on Clinical Trial Statistics: Survey
12/13/2022
 
 
TXT What’s Behind the New LASIK Guidance?
12/13/2022
 
 
TXT Assign TE Codes for All Approved Drugs: Study
12/13/2022
 
 
TXT Change Antibiotic Development Incentives: Study
12/13/2022
 
 
TXT Moderna/Merck Cancer Vaccine Meets Endpoint
12/13/2022
 
 
TXT Doc Group Wants FDA Probe of Musk’s Neuralink
12/13/2022
 
 
TXT Smiths Device Correction on CADD Infusion System
12/12/2022
 
 
TXT CVM Sees 1% Decrease in Food Animal Antimicrobial Use
12/12/2022
 
 
TXT Academics Urge FDA to Simplify Breast Density Notifications
12/12/2022
 
 
TXT DoJ Indictment on Unapproved Drugs
12/12/2022
 
 
TXT Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program
12/12/2022
 
 
TXT FDA Hits 2 QuVA Pharma Facilities with 483s
12/12/2022
 
 
TXT Green Pharmaceuticals’ SnoreStop ‘Adulterated’: FDA
12/11/2022
 
 
TXT Empowered Diagnostics Unapproved Covid Tests
12/11/2022
 
 
TXT FDA Will Review Pfizer Etrasimod NDA
12/11/2022
 
 
TXT Address Prescription Adderall Shortage: Spanberger
12/11/2022
 
 
TXT Academics Urge Tougher FDA Stance on Accelerated NDAs
12/09/2022
 
 
TXT Device Voluntary Malfunction Summary Reporting Guide
12/09/2022
 
 
TXT Remel Recalls Thermo Scientific Sensititre Plates
12/09/2022
 
 
TXT Janssen Files BLA for Myeloma Therapy
12/09/2022
 
 
TXT 2 Roche Alzheimer’s Tests Cleared by FDA
12/09/2022
 
 
TXT 10 Observations in Aurobindo Unit FDA-483
12/08/2022
 
 
TXT Non-Device Software Function Report
12/08/2022
 
 
TXT Draft VMSR Guidance for Manufacturers
12/08/2022
 
 
TXT 16 Observations on Lupin Unit FDA-483
12/08/2022
 
 
TXT FDA Proposes More Comprehensive IND Reports
12/08/2022
 
 
TXT Draft Device Human Factors Guidance
12/08/2022
 
 
TXT Comments on Pediatric Clinical Pharmacology Draft
12/08/2022
 
 
TXT FDA Manuscript in the Works on Trial Diversity Strategy
12/08/2022
 
 
TXT FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug
12/07/2022
 
 
TXT FDA Accelerated Approvals Down This Year: AP
12/07/2022
 
 
TXT FDA Denies Homeopathy Petition
12/07/2022
 
 
TXT Significant HCT/P Deviations at Cryos International
12/07/2022
 
 
TXT FDA Denies Petition on Scrubs as Medical Devices
12/07/2022
 
 
TXT PhRMA Issues with FDA Medical Queries
12/07/2022
 
 
TXT Device Shortages Need More Transparency: FDA
12/07/2022
 
 
TXT Coalition for Health AI Meeting Summary
12/07/2022
 
 
TXT FDA Defends Training/Support of Team Biologics
12/07/2022
 
 
TXT AG Hair Limited CGMP Issues
12/06/2022
 
 
TXT CGMP Violations at Glenmark Pharmaceuticals
12/06/2022
 
 
TXT CGMP Violations in Kari Gran Inspection
12/06/2022
 
 
TXT FDA Maintains ‘High Bar’ for P13K Inhibitors
12/06/2022
 
 
TXT FDA Developed New Covid Drug Surveillance: Study
12/06/2022
 
 
TXT Team Biologics Needs More Staff, Training: Former FDAers
12/06/2022
 
 
TXT Pass VALID Act Now: Former Commissioners
12/06/2022
 
 
TXT Guide on PK-Based Criteria for PD1/PD-L1 Alt Dosing
12/06/2022
 
 
TXT Contract Lab Valisure Relinquishes its Testing Prowess
12/06/2022
 
 
TXT FDA Updates Endologix Endovascular Graft Safety
12/06/2022
 
 
TXT Firms Seek EUA for Omicron Vaccine in Young Children
12/05/2022
 
 
TXT Novartis Seeking Expanded Pluvicto Use
12/05/2022
 
 
TXT Guide on ‘Selective’ Drug Safety Data Collection
12/05/2022
 
 
TXT Clinical Hold Issues Outlined for Cholesterol Gene Therapy
12/05/2022
 
 
TXT FDA Confirms Survival Rate With Abiomed’s Heart Device
12/05/2022
 
 
TXT Getinge Intra-Aortic Balloon Pumps on Shortage Lis
12/02/2022
 
 
TXT Draft Guide on Bioequivalence Statistical Approaches
12/02/2022
 
 
TXT Oncologic Drugs Committee Renewed for 2 Years
12/02/2022
 
 
TXT Biden Signs Medical Marijuana/Cannabidiol Research Law
12/02/2022
 
 
TXT Medtronic HeartWare ‘Dear Doctor’ Letter
12/01/2022
 
 
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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;
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