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FDA-RELATED NEWS
 
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TXT Inogen Airway Clearance Device Cleared
01/06/2025
 
 
TXT Guide on Clinical Trials Using Tissue Biopsies
01/06/2025
 
 
TXT Draft Guide on Using AI for Drug Development
01/06/2025
 
 
TXT Neumora’s Phase 3 Depression Study Misses Endpoints
01/06/2025
 
 
TXT CDER Approved 50 Novel Products Last Year
01/06/2025
 
 
TXT Axsome Plans Alzheimer’s NDA on Mixed Data
01/03/2025
 
 
TXT Exclude Liraglutide from Compounding: Novo Nordisk
01/03/2025
 
 
TXT Mylan 6-Item Form FDA-483 Posted
01/03/2025
 
 
TXT FDA Alert on Boston Accolade Pacers Early Replacement
01/03/2025
 
 
TXT FDA Approves Xcovery’s Ensacove for Some Lung Cancers
01/03/2025
 
 
TXT FDA Approves Humacyte’s Symvess
01/03/2025
 
 
TXT FDA Wants Labeling Changes for Buprenorphine
01/03/2025
 
 
TXT Bhargava Phytolab CGMP Violations
01/03/2025
 
 
TXT Global Unique Device ID Database Guidance
01/03/2025
 
 
TXT FDA Approves Novo Hemophilia Prophylaxis Drug
01/03/2025
 
 
TXT New Sleep Apnea Indication for Lilly’s Zepbound
01/03/2025
 
 
TXT Astellas Recalls Lots of Prograf and Astagraf
01/03/2025
 
 
TXT QS, MDR Violations at Rontis Hellas in Greece
01/03/2025
 
 
TXT FDA Approves BMS’ Opdivo Qvantig Injection
01/03/2025
 
 
TXT FDA Approves Checkpoint’s Unloxcyt
01/03/2025
 
 
TXT CGMP Violations in Micro Orgo Chem Inspection
01/03/2025
 
 
TXT Guide on Drug Batch Uniformity and Integrity
01/03/2025
 
 
TXT Chimerix NDA for Glioma Drug
01/03/2025
 
 
TXT Temple Retires; Bumpus Leaves FDA
01/02/2025
 
 
TXT Xbrane Refiles Lucentis Biosimilar BLA
01/02/2025
 
 
TXT Alert on AquaFlexFlow Blood Circuits
01/02/2025
 
 
TXT Senators Introduce Skinny Label Generic Drug Bill
01/02/2025
 
 
TXT Sombra Cosmetics CGMP Violations
01/02/2025
 
 
TXT FDA OKs Mesoblast’s Ryoncil Cell Therapy
01/02/2025
 
 
TXT Multiple Violations in BD Inspection
01/02/2025
 
 
TXT Clinical Investigation Protocol Deviations
01/02/2025
 
 
TXT Updated POLARx Instructions is Class 1 Recall: FDA
01/02/2025
 
 
TXT FDA Seeks Comments on ODAC Briefing Guidance
01/02/2025
 
 
TXT CGMP Violations in Akorn Formulations Review
01/02/2025
 
 
TXT ICH M15 Model-Informed Drug Development Principles
01/02/2025
 
 
TXT AMT Designation Program Guidance
01/02/2025
 
 
TXT ICH E11A Pediatric Extrapolation Guidance
01/02/2025
 
 
TXT ICH Clinical Practice Guide Annex
01/02/2025
 
 
TXT Brands International Limits, Delays Inspection: FDA
01/02/2025
 
 
TXT CRL for Zealand’s SBS Treatment NDA
01/02/2025
 
 
TXT Quality, Data Issues at Mylan Facility in India
01/02/2025
 
 
TXT Boxed Warning for Veozah Liver Injury
01/02/2025
 
 
TXT Lexicon Dropping Zynquista After CRL
01/02/2025
 
 
TXT Hologic BioZorb Marker Recall Class 1: FDA
01/02/2025
 
 
TXT UCB Minzasolmin Parkinson’s Study Misses Endpoints
01/02/2025
 
 
TXT FDA Alert on Baxter Solution Sets
01/02/2025
 
 
TXT Syndax Leukemia Review Extended by FDA
07/29/2024
 
 
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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:
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  • Summaries of the latest FDA Federal Register notices;
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