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FDA-RELATED NEWS
 
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TXT USP Launches Nitrosamines Analytical Hub
03/08/2023
 
 
TXT FDA Bioresearch Inspection Findings Out
03/08/2023
 
 
TXT Determine NMN is a Dietary Supplement: Petition
03/08/2023
 
 
TXT Lithium Citrate Not Withdrawn Due to Safety/Efficacy
03/07/2023
 
 
TXT FDA Extends Review Date for BioMarin’s Roctavian
03/07/2023
 
 
TXT FDA Highlights ‘Proactive and Innovative’ Opioid Research
03/07/2023
 
 
TXT Thomas Advanced Medical Illegally Selling HCT/Ps: FDA
03/07/2023
 
 
TXT FDA Withdraws Fosun ANDA for Pemoline
03/07/2023
 
 
TXT Abbott Alinity I Concussion Blood Test Cleared
03/07/2023
 
 
TXT Update Accelerated Approval Labels with Required Info: Study
03/07/2023
 
 
TXT More Hemodialysis Toxic Compound Analysis Needed: FDA
03/07/2023
 
 
TXT FDA Grants De Novo Device for Tinnitus
03/07/2023
 
 
TXT Aclaris Skin Condition Study Misses Endpoint
03/07/2023
 
 
TXT Some Guidance Changes Helpful, More Needed: AAM
03/07/2023
 
 
TXT Dupixent sBLA for Chronic Spontaneous Urticaria
03/07/2023
 
 
TXT Questions on Oncologic Investigational Agent Guidance
03/07/2023
 
 
TXT Incyte Abandons Phase 3 Myelofibrosis Trial
03/06/2023
 
 
TXT FreeStyle Sensors for Automated Insulin Delivery
03/06/2023
 
 
TXT FDA Increasing Oversight on Diethylene Glycol Contamination
03/06/2023
 
 
TXT Novartis Petitions FDA on Dosing Titration Info Requirement
03/06/2023
 
 
TXT ‘Priority’ for Alzheimer’s sBLA Seeking Traditional Approval
03/06/2023
 
 
TXT DoJ Preferring Deferred Prosecution Agreements: Attorneys
03/06/2023
 
 
TXT Exelixis Renal Cell Carcinoma Study Misses Endpoint
03/03/2023
 
 
TXT Drug Continuous Manufacturing Guidance
03/03/2023
 
 
TXT Veru EUA Request for Covid Drug Denied
03/03/2023
 
 
TXT Lilly Gets Expanded Indication for Verzenio
03/03/2023
 
 
TXT FloSpine 3D-Printed Interbody Cage Cleared
03/03/2023
 
 
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
 
 
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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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