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FDA-RELATED NEWS
 
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TXT CDER 2022 Drug Safety Priorities Report Out
03/02/2023
 
 
TXT FDA, FTC Advancing Biologic Competition
03/02/2023
 
 
TXT Panel to Review Lynparza sNDA for Prostate Cancer
03/02/2023
 
 
TXT Drug, Device Recalls Shoot Up in 2022: Report
03/02/2023
 
 
TXT 8 Observations in Cipla FDA-483
03/02/2023
 
 
TXT Many Deficiencies in Musk Neuralink Brain Chip: FDA
03/02/2023
 
 
TXT FDA, Expert Debate Bivalent Covid Vaccine Deployment
03/02/2023
 
 
TXT Q13 Drug Continuous Manufacturing Guidance
03/01/2023
 
 
TXT FDA Mulls Artificial Intelligence Use in Drug Manufacturing
03/01/2023
 
 
TXT Multiple Violations Seen in Skyless Inspection
03/01/2023
 
 
TXT Monoclonal Antibody Potency Assay Guidance
03/01/2023
 
 
TXT FDA Highlights Rare Disease Day 2023 with ARC
03/01/2023
 
 
TXT eSTAR Template ‘Early Learnings’: Regulation Expert
03/01/2023
 
 
TXT Panel Backs GSK Vaccine for RSV in Older Adults
03/01/2023
 
 
TXT Cytokinetics Gets NDA Complete Response Letter
03/01/2023
 
 
TXT 4 New CBER Standard Policies and Procedures
02/28/2023
 
 
TXT FDA Restricting Unlawful Importing of Xylazine
02/28/2023
 
 
TXT FDA, FTC Biosimilar Workshop Summary Out
02/28/2023
 
 
TXT Califf Expands on ORA Restructuring
02/28/2023
 
 
TXT Group Petitions for More Trial Reporting Enforcement
02/28/2023
 
 
TXT FDA Seeks Comments on AI Areas in Drug Manufacturing
02/28/2023
 
 
TXT CDER Neuroscience Director Dunn Leaving Agency
02/27/2023
 
 
TXT FDA Warning on Abbott Trifecta Heart Valves
02/27/2023
 
 
TXT FDA Raises Guillain-Barre Monitoring on RSV Vaccine
02/27/2023
 
 
TXT Verrica Pharma NDA Resubmitted for Skin Infection
02/27/2023
 
 
TXT FDA Debars Ex-Indivior CEO for 5 Years
02/27/2023
 
 
TXT CDER Taps Deputy Furman as Compliance Director
02/24/2023
 
 
TXT FDA Grants EUA for First OTC Flu/Covid Test
02/24/2023
 
 
TXT Chantix Not Withdrawn Due to Safety/Efficacy
02/24/2023
 
 
TXT Lawsuit Seeks REMS Removal on Mifepristone
02/24/2023
 
 
TXT Guide on ‘Wet Age’ Macular Degeneration Drugs
02/24/2023
 
 
TXT Califf Pushes Improved Evidence Generation System
02/24/2023
 
 
TXT Human Factor Guidance is FDA ‘Mission Creep’: Attorney
02/23/2023
 
 
TXT PhRMA Proposes Changes to M11 Guidance
02/23/2023
 
 
TXT CMS Continues Block on Alzheimer’s Drug Coverage
02/23/2023
 
 
TXT FDA Urged to Pull Failed Cancer Drugs Faster
02/23/2023
 
 
TXT Ivermectin Not Effective in Treating Covid: Study
02/23/2023
 
 
TXT FDA Evaluating Neonatal Incubator Airborne Chemicals
02/23/2023
 
 
TXT USPTO Should Check Keytruda Patent Requests: Lawmakers
02/23/2023
 
 
TXT Amneal Pharmaceuticals FDA-483 Released
02/22/2023
 
 
TXT Lessons Learned from Covid Vaccine Development
02/22/2023
 
 
TXT Asacol Not Withdrawn Due to Safety/Efficacy
02/22/2023
 
 
TXT Topamax Not Withdrawn Due to Safety/Efficacy
02/22/2023
 
 
TXT AAM Praises Controlled Correspondence Guidance
02/22/2023
 
 
TXT FDA Publishes 3 X-Ray Guidances
02/22/2023
 
 
TXT FDA Accepts Elranatamab BLA for Priority Review
02/22/2023
 
 
TXT Artificial Tears Warning Expanded
02/22/2023
 
 
TXT RapidAI RV/LV Analyzer for Pulmonary Embolism Cleared
02/22/2023
 
 
TXT High Court Refuses to Hear J&J Mesh Case
02/22/2023
 
 
TXT Akebia Vadadustat Dispute Resolution Delayed
02/21/2023
 
 
TXT FDA Extends Astellas Fezolinetant PDUFA Action Date
02/21/2023
 
 
TXT FDA Limited in Fighting Misinformation: Califf
02/21/2023
 
 
TXT 510(k) Guidances for 2 Ultrasound-type Devices Published
02/21/2023
 
 
TXT Intarcia Agrees to Advisory Committee to Resolve Review Dispute
02/21/2023
 
 
TXT Regulatory Agenda Eyes DTC Ads and Med Guides
02/21/2023
 
 
TXT Pfizer Drops Many U.S. Lyme Trial Participants
02/17/2023
 
 
TXT Priority Review for Merck Prevymis sNDA
02/17/2023
 
 
TXT FDA to Review Iveric NDA for Avacincaptad Pegol
02/17/2023
 
 
TXT Comments Sought on WHO Drug Scheduling
02/17/2023
 
 
TXT Eisai Expects FDA to Approve Alzheimer’s Drug Soon
02/17/2023
 
 
TXT FDA OKs Chiesi’s Lamzede for Alpha-Mannosidosis
02/17/2023
 
 
TXT Califf Sees Misinformation as Cause of Preventable Deaths
02/17/2023
 
 
TXT GE Recalls ‘Unstable’ Nuclear Medicine Devices
02/16/2023
 
 
TXT Drug R&D Can’t Justify High Prices: Study
02/16/2023
 
 
TXT Further FDA Opioid Crisis Strategies: Califf
02/16/2023
 
 
TXT 30 New Product-Specific Guidances Out
02/16/2023
 
 
TXT Pfizer Says Talzenna Prostate Cancer Study ‘Positive’
02/16/2023
 
 
TXT FDA Approves BioVex BLA Supplement
02/16/2023
 
 
TXT GAO Identifies FDA Gaps in IRB Oversight
02/16/2023
 
 
TXT FDA Pushed Into Accelerated Approval Pricing Model
02/15/2023
 
 
TXT MCM Annual Report Achievements
02/15/2023
 
 
TXT FDA Keeps Concert Drug’s Breakthrough Status
02/15/2023
 
 
TXT Court Action on 3 Claims Explained
02/15/2023
 
 
TXT Pediatric Drug Extrapolation in U.S. Analyzed
02/15/2023
 
 
TXT Bryan Concerns About Gene Therapy Accelerated OKs
02/15/2023
 
 
TXT FDA Facing Backlog of ODE Determinations: Attorneys
02/15/2023
 
 
TXT AdvaMed Comments on Inspection Delay Guidance
02/15/2023
 
 
TXT Panel Unanimously Backs Non-Rx Narcan
02/15/2023
 
 
TXT CGMP Violations in Delta Kozmetik Sanayi Inspection
02/14/2023
 
 
TXT Multiple Violations in Unapproved Wintech Medipro Masks
02/14/2023
 
 
TXT 11 Republicans See FDA/Industry ‘Revolving Door’
02/14/2023
 
 
TXT FDA Alternative Review Tools ‘Critical’ in Decisions: Study
02/14/2023
 
 
TXT Marks Wants ‘Project Orbis’ for Cell/Gene Therapies
02/14/2023
 
 
TXT FDA Learning to Combat Social Media Disinformation
02/14/2023
 
 
TXT Benefit-Risk is Top CBER Panel Issue: FDA
02/13/2023
 
 
TXT Ocuphire Pharma NDA for Eye Dilation Reversal
02/13/2023
 
 
TXT Repackaging Propofol During Covid Guide Withdrawn
02/13/2023
 
 
TXT 10% of FDA-approved Drugs Had Null Findings: JAMA
02/13/2023
 
 
TXT Inspection Troubles Hit Biocon’s Avastin Biosimilar
02/13/2023
 
 
TXT Ethicon $10 Million Settlement Over Surgical Mesh
02/13/2023
 
 
TXT Neonatal Neurodevelopmental Safety Study Guide
02/10/2023
 
 
TXT ODAC Panel Backs Proposed Jemperli Studies
02/10/2023
 
 
TXT New AI Tools Will Require FDA Flexibility: Califf
02/10/2023
 
 
TXT HHS Roadmap Outlines FDA Flexibilities Post-Covid
02/10/2023
 
 
TXT Phathom Gets 2 Complete Response Letters Over Impurity
02/10/2023
 
 
TXT FDA to Explain Post-Health Emergency Effects
02/09/2023
 
 
TXT Eiger Won’t Seek EUA for Interferon Covid Treatment: Bloomberg
02/09/2023
 
 
TXT FDA Updates Philips MDRs; 82 Deaths in 2 Months
02/09/2023
 
 
TXT FDA Denies DuraSeal Spinal Sealant Petition
02/09/2023
 
 
TXT DoJ Wants Conspiracy Charge Against KVK-Tech
02/09/2023
 
 
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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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