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FDA-RELATED NEWS
 
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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 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 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 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
 
 
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