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FDA-RELATED NEWS
 
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TXT Cardinal Health Recalls Monoject Syringes
02/02/2024
 
 
TXT Benefits/Challenges of Decentralized Trials: Commentary
02/02/2024
 
 
TXT 7 ex-FDA Commissioners Weigh In on Mifepristone
02/02/2024
 
 
TXT Rep. Waltz Questions FDA’s Telework Policy
02/02/2024
 
 
TXT Edwards Tricuspid Valve Replacement Approved
02/02/2024
 
 
TXT Four FDA-483s Released
02/01/2024
 
 
TXT AI in Clinical Decision Tools Will Challenge FDA: Califf
02/01/2024
 
 
TXT 2 Veterinary Medicine Guidances Published
02/01/2024
 
 
TXT FDA OKs NeuroBo Obesity Drug Phase 1 Trial
02/01/2024
 
 
TXT Adaptimmune BLA for Synovial Sarcoma Accepted
02/01/2024
 
 
TXT Diabetes Digital Health Comments
02/01/2024
 
 
TXT Final QS Rule for International Harmonization
01/31/2024
 
 
TXT Revised Biosimilar Research Roadmap Out
01/31/2024
 
 
TXT Hearing on FDA Foreign Inspections
01/31/2024
 
 
TXT Biogen Abandoning Aduhelm in Alzheimer’s Re-focus
01/31/2024
 
 
TXT Clinical Study Diversity Workshop Comments
01/31/2024
 
 
TXT GE Recalls Ventilator Air Compressors
01/31/2024
 
 
TXT Congressional Dems Ask SCOTUS Mifepristone Reversal
01/31/2024
 
 
TXT Respironics Reports 111 Deaths in 3Q 2023: FDA
01/31/2024
 
 
TXT Guide on Monoclonal Antibodies Docket Correction
01/31/2024
 
 
TXT World Cancer Day Treatment Virtual Discussion
01/30/2024
 
 
TXT Defender Pharma ‘Complete Response’ on Nausea Drug
01/30/2024
 
 
TXT Musk Reports Implanting 1st Chip in Human Brain
01/30/2024
 
 
TXT Feds Looking at Medical Record AI: Bloomberg
01/30/2024
 
 
TXT Ban Skin Shock Devices: 29 Associations
01/30/2024
 
 
TXT CGMP Violations at Thailand’s S&J International
01/30/2024
 
 
TXT Court Orders FDA Hetlioz Action
01/30/2024
 
 
TXT Philips Respironics, FDA Reach Consent Decree
01/29/2024
 
 
TXT Human Genome Editing Product Development Guide
01/29/2024
 
 
TXT CAR T-Cell Development Considerations Guide
01/29/2024
 
 
TXT Guide on Race/Ethnicity Data Reporting
01/29/2024
 
 
TXT Senator Targets Firms Over Improper Patents
01/29/2024
 
 
TXT Positive Data in Keytruda Kidney Cancer Trial
01/29/2024
 
 
TXT De Novo OK for Google Phone Thermometer
01/26/2024
 
 
TXT Postmarketing Drug Surveillance Best Practices
01/26/2024
 
 
TXT FDA Should Identify AI Legislative Changes: GAO
01/26/2024
 
 
TXT ICH Guide on Analytical Procedure Development
01/26/2024
 
 
TXT Remote Regulatory Assessments Draft Guide
01/26/2024
 
 
TXT Merck Keytruda Data Positive in Bladder Cancer
01/26/2024
 
 
TXT FDA Delays Review Action on Liquidia NDA
01/25/2024
 
 
TXT FDA Featured in 2024 ‘Top-of-Mind Issues’ Report
01/25/2024
 
 
TXT QMM Protocol Volunteers Sought
01/25/2024
 
 
TXT Guide on Revising ANDA Labeling
01/25/2024
 
 
TXT 11 Observations on Hybrid Pharma FDA-483
01/25/2024
 
 
TXT New HCP Drug Interaction Web Site
01/25/2024
 
 
TXT Dupixent Wins FDA Expanded Indication
01/25/2024
 
 
TXT AI-Assisted Chest X-ray Cleared
01/25/2024
 
 
TXT Vitacell Biologics Illegally Selling Cellular Products: FDA
01/25/2024
 
 
TXT 22 T-Cell Cancers After CAR-T Treatment: CBER
01/25/2024
 
 
TXT Final ANDA Label Revision Guidance
01/24/2024
 
 
TXT 1st ISTAND Pilot AI Submission Accepted
01/24/2024
 
 
TXT Animal Drug API GMP Guidance
01/24/2024
 
 
TXT FDA Subscribes to digiM I2S Software
01/24/2024
 
 
TXT Stakeholder Input on Innovative Trial Workshop
01/24/2024
 
 
TXT Groups Urge Hearing on CBD Regulation
01/24/2024
 
 
TXT ANDA Final Approval Guidance
01/24/2024
 
 
TXT Theratechnologies ‘Complete Response’ on Tesamorelin
01/24/2024
 
 
TXT CDRH Tech Innovation Group Now a Super Office
01/24/2024
 
 
TXT Positive Gene Therapy Results for Some Hearing Loss
01/24/2024
 
 
TXT Breakthrough Status for Colorectal Cancer Test
01/23/2024
 
 
TXT CGMP Deviations Seen in Glicerinas Inspection
01/23/2024
 
 
TXT FDA Accepts Autolus Obe-Cel BLA
01/23/2024
 
 
TXT FDA Orders Safety Changes to 5 CAR-T Labels
01/23/2024
 
 
TXT Court Allows 1 Vanda Claim Against FDA
01/23/2024
 
 
TXT FDA, FTC Should Regulate ‘Influencer’ Posts: Column
01/23/2024
 
 
TXT Orthopedic Device Coatings Guidance
01/23/2024
 
 
TXT Pharvaris Clinical Hold Lifted
01/22/2024
 
 
TXT Draft Guide on Orthopedic Device Coatings
01/22/2024
 
 
TXT De Novo OK for Osteopenia Device
01/22/2024
 
 
TXT Gilead Trodelvy Trial Misses Endpoint
01/22/2024
 
 
TXT Info Collection on Rx Drug Marketing
01/22/2024
 
 
TXT OPDP Letter Cites Novartis on Kisqali Ad
01/22/2024
 
 
TXT Globus Recalls Fluoroscopy Fixture Kit
01/19/2024
 
 
TXT Boxed Warning Added to Amgen’s Prolia
01/19/2024
 
 
TXT Klobuchar Targets Improper Patent Listings
01/19/2024
 
 
TXT Alvotech Reinspection Lands 1 Observation
01/19/2024
 
 
TXT Lilly Inspection Cites 8 Findings: Report
01/19/2024
 
 
TXT FDA, CMS Reiterate Need for FDA Test Oversight
01/18/2024
 
 
TXT SCOTUS May Tighten ‘Chevron Deference’: Attorneys
01/18/2024
 
 
TXT CDRH Sets Marketing Authorization Record
01/18/2024
 
 
TXT U.S. Reassures Canada on Drug Imports
01/18/2024
 
 
TXT Package Level Drug Distribution Security Guidance
01/18/2024
 
 
TXT Satsuma ‘Complete Response’ on Migraine Drug
01/18/2024
 
 
TXT Megadyne Mega Soft Electrode Recall is Class 1
01/17/2024
 
 
TXT GAO Probing FDA Ventilator Recall Actions
01/17/2024
 
 
TXT Reducing the Potential for Pulse Oximeter Bias
01/17/2024
 
 
TXT FDA Needs Help in Regulating Algorithms: Califf
01/17/2024
 
 
TXT DermaSensor AI Skin Cancer Detector Cleared
01/17/2024
 
 
TXT Reschedule Marijuana to Schedule 3: FDA
01/17/2024
 
 
TXT Multiple Violations at Dr. Joel Kaplan Inc.
01/16/2024
 
 
TXT Docs Don’t Understand FDA Approval Process: Research
01/16/2024
 
 
TXT Hemogenyx Responds to Clinical Hold
01/16/2024
 
 
TXT Clinical Trial Modernization and Innovation Meeting
01/16/2024
 
 
TXT Vertex Pharma Gets 2nd OK for Gene Therapy
01/16/2024
 
 
TXT Alert on Equinoxe Shoulder Implants
01/16/2024
 
 
TXT Matsui, Buschon Introduce Drug Shortage Bill
01/16/2024
 
 
TXT FDA ‘Off-Label’ Enforcement Increasing: Attorney
01/16/2024
 
 
TXT Court Cuts Covid Vaccine FOIA Stay to 6 Months
01/16/2024
 
 
TXT 45% of CDER Warning Letters Cited GMPs: Report
01/12/2024
 
 
TXT Darmiyan De Novo for Alzheimer’s Assessor
01/12/2024
 
 
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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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