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FDA-RELATED NEWS
 
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TXT Senate Judiciary Committee Clears 5 Drug Bills
02/09/2023
 
 
TXT CBER in a ‘Transition Year’: Marks
02/08/2023
 
 
TXT EUA for BD Combination Covid-Flu-RSV Test
02/08/2023
 
 
TXT FDA Unsure of ‘Unprecedented’ Jemperli Trial Plans
02/08/2023
 
 
TXT Industry VMSR Improvement Suggestions
02/08/2023
 
 
TXT CDER Researches Convolutional Neural Networks
02/08/2023
 
 
TXT Califf Sails Through 1st Covid Oversight Hearing
02/08/2023
 
 
TXT QS, Other Violations at Getsch+Hiller Medizintechnik
02/07/2023
 
 
TXT FDA Criminal Probe Nets Device Maker Indictment
02/07/2023
 
 
TXT 8 Inspection Takeaways from New FDA Law
02/07/2023
 
 
TXT OCE Slowed New Projects in 2022
02/07/2023
 
 
TXT Comments on FDA/Patent Office Collaboration
02/07/2023
 
 
TXT Kessler Praises Marks on Covid Response Leadership
02/07/2023
 
 
TXT Lower Added Benefit Associated with Higher DTC Spend
02/07/2023
 
 
TXT Court Throws Out PhRMA Lawsuit on Drug Importation
02/07/2023
 
 
TXT FDA Offers Advisory Committee Hearing on Intarcia Dispute
02/07/2023
 
 
TXT FDA Urges Reporting of Home Covid Test Results
02/06/2023
 
 
TXT Rapid-Acting Depression Drug Gets Priority Review
02/06/2023
 
 
TXT MD Sentenced in Avanir Kickbacks
02/06/2023
 
 
TXT Abbott Expanded Indication for Ablation Catheter
02/06/2023
 
 
TXT Tezspire Approved as Pre-filled Pen for Asthma
02/06/2023
 
 
TXT Sandoz Prolia/Xgeva Biosimilar BLA Submitted
02/06/2023
 
 
TXT Man Fakes Cancer to Skip FDA Misbranding Trial
02/03/2023
 
 
TXT Device Co. Pays $500K over False Claims: DoJ
02/03/2023
 
 
TXT Trodelvy OK’d for Pre-treated Metastatic Breast Cancer
02/03/2023
 
 
TXT Senators Urge Danco Labs to Expand Mifepristone’s Use
02/03/2023
 
 
TXT Attorneys Dismiss ‘Hype’ on FDORA Animal Testing Provision
02/03/2023
 
 
TXT FDA Clinical Hold on 4D Molecular Fabry Drug
02/03/2023
 
 
TXT Device Conformity Assessment Pilot Becoming Permanent
02/03/2023
 
 
TXT GSK’s Oral Anemia Drug Approved for Dialysis
02/02/2023
 
 
TXT Greenleaf Health Hires 2 Former FDA Officials
02/02/2023
 
 
TXT FDA Warning, Import Alert on Contaminated Eyedrops
02/02/2023
 
 
TXT Philips BiPAP, CPAP Mask Recall is Class 1: FDA
02/02/2023
 
 
TXT FDA Strategy on Opioid Reversal Products Nears Fruition
02/02/2023
 
 
TXT PMR/PMC Annual Statistical Report
02/02/2023
 
 
TXT Consider Mfg. Issues in Preparedness Planning: GAO
02/02/2023
 
 
TXT GoodRx Paying $1.5 Million for Consumer Data Breach
02/02/2023
 
 
TXT Ways to Mitigate Park Doctrine Risks: Attorney
02/02/2023
 
 
TXT Expanded Indication for Abbott Heart Catheter
02/02/2023
 
 
TXT Fraudulent Contract Research Org. Leads to Debarment
02/02/2023
 
 
TXT Glucosamine Case Can Inform Drug, Device Cases: Attorney
02/02/2023
 
 
TXT M13A Bioequivalence Consensus Guideline
02/01/2023
 
 
TXT Positive Covid Test Requirement Lifted on 2 Therapeutics
02/01/2023
 
 
TXT No Justification for Lexicon Hearing: CDER
02/01/2023
 
 
TXT CDER Planning 98 New, Revised Guidances for 2023
02/01/2023
 
 
TXT Lyme Disease Drug Development Guidance
02/01/2023
 
 
TXT IBSA Recalls Some Tirosint-Sol Lots
02/01/2023
 
 
TXT Clarius Mobile’s Musculoskeletal AI Measurer
02/01/2023
 
 
TXT Xenex Files De Novo for Disinfection Device
02/01/2023
 
 
TXT RightEye Promoting Off-Label Use: FDA
01/31/2023
 
 
TXT Multiple Violations at Adept Life Science
01/31/2023
 
 
TXT GDUFA 2022 Science and Research Report
01/31/2023
 
 
TXT Improve Biosimilar Development and Approval Efficiency
01/31/2023
 
 
TXT Externally Controlled Trial Guidance
01/31/2023
 
 
TXT FDA 'Defying' Appeals Court is Troubling: Attorneys
01/31/2023
 
 
TXT CBER 2023 Guidance Agenda
01/31/2023
 
 
TXT Biden Administration Ending Public Health Emergency 5/11
01/31/2023
 
 
TXT CBER Tissues/Advanced Therapies Director Bryan Retiring
01/31/2023
 
 
TXT Califf Proposes ‘Transformation’ of Foods Program, ORA
01/31/2023
 
 
TXT Class 1 Recall of Smiths CADD Infusion Sets
01/31/2023
 
 
TXT Guide on Lasers for Surveying, Leveling and Aligning
01/30/2023
 
 
TXT Class 1 Recall of Medtronic ‘Leaky’ Catheters
01/30/2023
 
 
TXT Guide on Acromegaly Drug Development
01/30/2023
 
 
TXT Consent Decree Against LGM Pharma
01/30/2023
 
 
TXT CDER/CBER Restarting In-Person Industry Meetings
01/30/2023
 
 
TXT Oracle Technology Guru Named FDA Digital Health Director
01/30/2023
 
 
TXT Lawsuit Against FDA and Livestock/Poultry Antibiotic Use
01/27/2023
 
 
TXT FDA Funding Opportunity for Pediatric Device Consortia
01/27/2023
 
 
TXT New Data Support Carvykti sNDA in Multiple Myeloma
01/27/2023
 
 
TXT Vanda Petitions FDA Over Teva ‘Non-Braille’Labeling
01/27/2023
 
 
TXT FDA Denies Petition on Jakafi Safety Labeling
01/27/2023
 
 
TXT Eschoo Reelected as Ranking Dem on Health Subcommittee
01/27/2023
 
 
TXT LivaNova Again Recalls LifeSPARC Controller Over Software
01/27/2023
 
 
TXT Rep. Guthrie to Chair FDA Oversight Committee
01/26/2023
 
 
TXT FDORA Requires Trial Diversity Action Plans: Attorneys
01/26/2023
 
 
TXT New CBD Regulatory Framework Needed: Woodcock
01/26/2023
 
 
TXT Biological Therapies Need Clinical Trials: Califf, Marks
01/26/2023
 
 
TXT Include all Media in Drug Promotion Regs: Professors
01/26/2023
 
 
TXT CDRH OK’d 19 Breakthrough Devices in 2022
01/26/2023
 
 
TXT Dental Practices Defrauded FDA: Justice Dept.
01/26/2023
 
 
TXT Torrent Inspection Classified as Official Action Indicated
01/26/2023
 
 
TXT No Evidence of Contaminated Cough Syrup in U.S.: FDA
01/26/2023
 
 
TXT Panel Backs Plan to Harmonize Covid Vaccine Composition
01/26/2023
 
 
TXT Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions
01/25/2023
 
 
TXT Final Guide on Compounding Ibuprofen Suspensions
01/25/2023
 
 
TXT Cardiosave Intra-Aortic Balloon Pumps Recalled
01/25/2023
 
 
TXT Improving Myelodysplastic Syndromes Trials
01/25/2023
 
 
TXT FDA Lifts Hold on Inhibikase Parkinson’s Trial
01/25/2023
 
 
TXT BsUFA Regulatory Research Roadmap
01/25/2023
 
 
TXT FDA/Aetion Oncology RWD Research
01/25/2023
 
 
TXT GenBioPro Sues to Overturn WV Abortion Pill Law
01/25/2023
 
 
TXT Merck Ending Keytruda Phase 3 Prostate Cancer Trial
01/25/2023
 
 
TXT Panel Votes to Approve Cidara’s Rezafungin
01/25/2023
 
 
TXT ‘7 Deadly Sins’ at FDA Presentations: Mikkael Sekeres
01/24/2023
 
 
TXT Biogen’s Lou Gehrig’s NDA Heads to Panel Review
01/24/2023
 
 
TXT AdvaMed Device Sterilization Reg Proposals for EPA
01/24/2023
 
 
TXT Lobbying Killed VALID Act: ProPublica
01/24/2023
 
 
TXT Many Advertised Drugs Have Low Therapeutic Value: Study
01/24/2023
 
 
TXT ‘Objectionable Conditions’ in Larkin Hospital IRB
01/24/2023
 
 
TXT ‘Corrective Recall’ Asked for Hemodialysis Units
01/24/2023
 
 
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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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