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FDA-RELATED NEWS
 
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TXT Athenex Cell Therapy on Clinical Hold
03/20/2023
 
 
TXT Remote Assessments May Be Model for Device Inspections
03/20/2023
 
 
TXT Accelerated Approval Mulled for Biogen’s Tofersen
03/20/2023
 
 
TXT Ipsen NDA Resubmission for Palovarotene
03/17/2023
 
 
TXT Sarepta BLA Needs Panel Review: FDA
03/17/2023
 
 
TXT Guide on Pharmacogenomic Data Submissions
03/17/2023
 
 
TXT FDA Hits Olympus with Warning Letter
03/17/2023
 
 
TXT CDER Posts Annual Office of Compliance Report
03/17/2023
 
 
TXT Datascope’s Cardiosave Heart Pumps Recalled
03/17/2023
 
 
TXT Medical Foods Q&A Guidance
03/16/2023
 
 
TXT Drug Supply Guide on Illegitimate/Suspect Products
03/16/2023
 
 
TXT FDA Clears BD Vaginitis Test
03/16/2023
 
 
TXT Glaxo MenABCWY Vaccine Hits 11 Endpoints
03/16/2023
 
 
TXT IPRP Cell/Gene Therapy Raw Materials Paper
03/16/2023
 
 
TXT Senate Appropriators Announce 4/19 FDA Budget Hearing
03/16/2023
 
 
TXT Panel Votes to Support Paxlovid NDA Approval
03/16/2023
 
 
TXT Community Should Push AA Drug Studies: Califf
03/16/2023
 
 
TXT PhRMA Comments on Drug Labeling Guidance
03/15/2023
 
 
TXT Janssen Vaccine Warning on Myocarditis/Pericarditis
03/15/2023
 
 
TXT FDA Clears Telehealth Respiratory Wheeze Detector
03/15/2023
 
 
TXT Clinical Investigation Electronic Systems Guidance
03/15/2023
 
 
TXT Bill to Streamline Generic Drug Approvals
03/15/2023
 
 
TXT Former Drug Sales Rep Pleads Guilty
03/15/2023
 
 
TXT FDA Reviewers Seem Positive on Paxlovid NDA
03/15/2023
 
 
TXT Mixed Stakeholder Views on Orange Book Listings
03/15/2023
 
 
TXT Profounda ‘Significant’ CGMP Violations
03/14/2023
 
 
TXT House GOP Probes Covid ‘Political Interference’ at FDA
03/14/2023
 
 
TXT More Comments on Patent Office/FDA Collaboration
03/14/2023
 
 
TXT Characterizing MRD Data in Cancer Trials
03/14/2023
 
 
TXT Petition Against BD’s Breast Reconstruction Device
03/14/2023
 
 
TXT CGMP Violations at Formology Lab
03/14/2023
 
 
TXT ‘Objectionable Conditions’ at Avanti Study Site: FDA
03/14/2023
 
 
TXT FDA Webview Reaches Out for Your Guidance
03/13/2023
 
 
TXT FDA Clears PeekMed Orthopedic Surgery Planner
03/13/2023
 
 
TXT Most Drug Shortages are Manufacturing Related: FDA
03/13/2023
 
 
TXT FDA Clinical Hold on Mersana Tumor Drug
03/13/2023
 
 
TXT Guide on Gastric pH-Dependent Drug Interactions
03/13/2023
 
 
TXT FDA/CDC Correct Florida Official’s Vaccine ‘Misinformation’
03/13/2023
 
 
TXT Panel to Review Entasis Therapeutics NDA
03/10/2023
 
 
TXT GAO Report Hits FDA on Advanced Manufacturing Tracking
03/10/2023
 
 
TXT FDA Outlines Disposition of Covid-19 Guidances
03/10/2023
 
 
TXT Pfizer NDA for Migraine Nasal Spray OK’d
03/10/2023
 
 
TXT 18 Senators Want End to Accelerated Approval Pricing Model
03/10/2023
 
 
TXT Baxter Device Correction for Life2000 Ventilator
03/10/2023
 
 
TXT FDA, EMA Parallel Scientific Advice is Effective: Study
03/09/2023
 
 
TXT Lilly Drops Solanezumab on Negative Results
03/09/2023
 
 
TXT How Can FDA Combat Medical Misinformation?
03/09/2023
 
 
TXT FDA Seeks $372 Million (10%) Budget Boost for FY 2024
03/09/2023
 
 
TXT Former Stimwave CEO Indicted
03/09/2023
 
 
TXT FDA Updates EUA Listing for Medical Devices
03/09/2023
 
 
TXT Mesoblast Remestemcel-L BLA Resubmitted
03/08/2023
 
 
TXT Updated Safety Alert on Breast Implant Cancer
03/08/2023
 
 
TXT FDA Accepts BioMarin Voxzogo New Indication sBLA
03/08/2023
 
 
TXT Covis Willing to Voluntarily Withdraw Makena
03/08/2023
 
 
TXT FDA’s Cancer Patient-Focused Glossary
03/08/2023
 
 
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
 
 
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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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