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FDA-RELATED NEWS
 
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TXT Octapharma’s Fibryga OK’s for Expanded Use
08/02/2024
 
 
TXT Updated CDER Guidance Agenda
08/01/2024
 
 
TXT M12 Drug Interaction Q&A
08/01/2024
 
 
TXT Durbin, Cassidy Introduce Drug Competition Bill
08/01/2024
 
 
TXT Psychopharmacologic Drugs Panel Renewal
08/01/2024
 
 
TXT FDA Explains New LabelComp Tool
08/01/2024
 
 
TXT FDA OKs Expanded Jemperli Indication
08/01/2024
 
 
TXT Abbott Device Correction on FreeStyle Libre 3
08/01/2024
 
 
TXT Novartis Sues FDA to Reverse Generic Entresto OK
08/01/2024
 
 
TXT Telix Pharma Hit with Refuse-to-File on BLA
08/01/2024
 
 
TXT Stakeholder Comments on Cell, Gene Guidance
07/31/2024
 
 
TXT FDA Publishes ICH Bioequivalence Guidance
07/31/2024
 
 
TXT FDA May Allow Novel Carve-Ins: Attorneys
07/31/2024
 
 
TXT Man Indicted for Selling Counterfeit Cancer Drugs
07/31/2024
 
 
TXT New Quantitative Medicine CoE Resources
07/31/2024
 
 
TXT OTC Monograph FY 2025 User Fee Rates
07/31/2024
 
 
TXT CDER Used AI/ML in Kineret EUA
07/31/2024
 
 
TXT Alert on Megadyne Patient Return Electrodes
07/31/2024
 
 
TXT Ways to Improve OS Data Collection, Analysis
07/31/2024
 
 
TXT Medical Device User Fee Rates
07/30/2024
 
 
TXT Prescription Drug User Fee Rates Set
07/30/2024
 
 
TXT Amco Illegally Selling AED Batteries: FDA
07/30/2024
 
 
TXT OSE Involved in 55 Novel Drug Approvals
07/30/2024
 
 
TXT Vertex NDA for Pain Drug Accepted for Review
07/30/2024
 
 
TXT Require Nasal Spray Food Studies: Aquestive
07/30/2024
 
 
TXT Amazon, Walmart Illegally Sell Chemical Peels
07/30/2024
 
 
TXT FDA Denies Public Citizen Tramadol Petition
07/30/2024
 
 
TXT Novartis sNDA for Scemblix Expanded Use
07/30/2024
 
 
TXT Syndax Leukemia Review Extended by FDA
07/29/2024
 
 
TXT Colon Cancer Blood Test Approved
07/29/2024
 
 
TXT AstraZeneca Reports Favorable Calquence Data
07/29/2024
 
 
TXT Kaleo Social Media Post Runs Afoul of FDA
07/29/2024
 
 
TXT Carie Boyd Pharma Hit with FDA-483
07/29/2024
 
 
TXT Alpha Cognition’s Zunveyl OK’d for Alzheimer’s
07/29/2024
 
 
TXT Elixir Med. Breakthrough Status for Bioadaptive Implant
07/29/2024
 
 
TXT Brassica Pharma Hit with 10-item FDA-483
07/26/2024
 
 
TXT Sun’s JAK Inhibitor OK’d for Alopecia Areata
07/26/2024
 
 
TXT Pulmonary-Allergy Drugs Panel Renewal
07/26/2024
 
 
TXT Alert on Compounded Semaglutide Overdoses
07/26/2024
 
 
TXT FDA Slaps Hold on Diabetes Investigational Drug
07/26/2024
 
 
TXT Blog Post on Device AI Lifecycle Model
07/26/2024
 
 
TXT bioMérieux Respiratory/Sore Throat Panel Cleared
07/26/2024
 
 
TXT Aurobindo Recalls Healthy Living Migraine Relief
07/25/2024
 
 
TXT VICH Residual Solvents Guidance
07/25/2024
 
 
TXT Guide on e-Health Records to Support Submissions
07/25/2024
 
 
TXT Medtronic Recalls NIM Vital Nerve Monitor
07/25/2024
 
 
TXT Covid-19 Convalescent Plasma Guidance
07/25/2024
 
 
TXT Recommend Transition to HTS Technology: MIT Letter
07/25/2024
 
 
TXT House FDA Budget Bill Floor Vote Scrapped
07/25/2024
 
 
TXT Abbott Recalls FreeStyle Libre 3 Sensors
07/25/2024
 
 
TXT FDA Fast Track for AC Immune Alzheimer’s Drug
07/25/2024
 
 
TXT Shuren Retiring; Tarver is Acting CDRH Director
07/24/2024
 
 
TXT FDA Wants Host Cell Protein Immunogenicity Info
07/24/2024
 
 
TXT Biocon Biosphere FDA-483
07/24/2024
 
 
TXT Pfizer Optimistic on Hemphilia A Gene Therapy
07/24/2024
 
 
TXT FDA Seeks Input on Biosimilar Guidance Development
07/24/2024
 
 
TXT RWD in Regulatory Decisions Guidance
07/24/2024
 
 
TXT Glass Vial, Stopper Guidance
07/24/2024
 
 
TXT Common BIMO Violations Listed
07/24/2024
 
 
TXT FDA Denies Novartis Entresto Petition
07/24/2024
 
 
TXT CGMP Violations at Yahon Enterprise
07/23/2024
 
 
TXT Comment Period Extended on FDA IT Strategy
07/23/2024
 
 
TXT Input on Non-Device Software Functions
07/23/2024
 
 
TXT Brassica Pharma CGMP Violations
07/23/2024
 
 
TXT QS Issues in Criticare Inspection
07/23/2024
 
 
TXT FDA Posts Laboratory-Developed Test FAQs
07/23/2024
 
 
TXT Merck Touts Clesrovimab Data in RSV
07/23/2024
 
 
TXT Group Outlines Considerations for OS Analyses
07/23/2024
 
 
TXT Genentech sBLA for Susvimo Accepted for Review
07/23/2024
 
 
TXT FDA Corrects Xenpozyme Patent Notice
07/22/2024
 
 
TXT J&J Seeks Spravato as Monotherapy in Depression
07/22/2024
 
 
TXT Samsung's Soliris Biosimilar Approved
07/22/2024
 
 
TXT DTC Ad Study Finds Benefit/Risk Conflation
07/22/2024
 
 
TXT Ionis Upbeat on Angelman Drug Study
07/22/2024
 
 
TXT FDA Clears Latest Ethos Radiotherapy System
07/22/2024
 
 
TXT Biosimilar Postapproval Manufacturing Change Guide
07/22/2024
 
 
TXT Mainz Seeks Breakthrough Status for Colon Cancer Test
07/19/2024
 
 
TXT Device Chemical Analysis for Biocompatibility
07/19/2024
 
 
TXT Diamyd Granted Fast Track for Diabetes
07/19/2024
 
 
TXT Spectralis Optical Coherence Tomography Module Cleared
07/19/2024
 
 
TXT Phelan-McDermid Therapy Given Rare Disease Status
07/19/2024
 
 
TXT FDA ‘Discourages’ BOT/BAL Accelerated Approval
07/18/2024
 
 
TXT Zydus Gets ‘Official Action Indicated’ on Recent Inspection
07/18/2024
 
 
TXT Aveo Phase 3 Trial Misses Primary Endpoint
07/18/2024
 
 
TXT Breakthrough Status for Heart Failure Device
07/18/2024
 
 
TXT Phathom Pharma Heartburn Drug Expanded Use
07/18/2024
 
 
TXT 2 More Warning Letters for Chinese Plastic Syringes
07/18/2024
 
 
TXT Human Radiolabeled Mass Balance Study Guide
07/18/2024
 
 
TXT 7 Observations in Leiters Health FDA-483
07/18/2024
 
 
TXT Baxter Recalls Volara System Ventilator Adapter
07/17/2024
 
 
TXT Comments Extended for Guide on Platform Technology
07/17/2024
 
 
TXT FDA Opening Rare Disease Innovation Hub
07/17/2024
 
 
TXT Blood Donor Eligibility Compliance Policy
07/17/2024
 
 
TXT Endo Recalls 1 Lot of Clonazepam
07/17/2024
 
 
TXT Bayer Looking to Expand Nubeqa Indication
07/17/2024
 
 
TXT Priority Review for Atara Gene Therapy
07/17/2024
 
 
TXT Almost 3,000 Establishment Inspections in FY 2023
07/17/2024
 
 
TXT Philips Updates Ventilator Instructions
07/17/2024
 
 
TXT GMP Violations in YangZhou Records Review
07/16/2024
 
 
TXT CGMP Violations at Jiangsu Hengrui
07/16/2024
 
 
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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:
  • The latest agency policy developments, often before they're officially announced;
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  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
  • Related industry news capsules;
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