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FDA-RELATED NEWS
 
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TXT FDA Tightening ‘Research Use Only’ Tests: Lawyers
04/25/2024
 
 
TXT Fresenius Recalls Stay-Safe Catheter Sets
04/25/2024
 
 
TXT Cancer Trial Performance Status Eligibility Criteria
04/25/2024
 
 
TXT Laboratory Values Cancer Trial Eligibility Criteria
04/25/2024
 
 
TXT Cardinal Health Monoject Inspection Violations
04/25/2024
 
 
TXT InfuTronix Recalls Malfunctioning Infusion Pumps
04/25/2024
 
 
TXT Cut Ozempic/Wegovy Price: HELP Committee
04/24/2024
 
 
TXT Curio Postpartum Depression Device Cleared
04/24/2024
 
 
TXT Zydus Lifesciences Issued Another FDA-483
04/24/2024
 
 
TXT Dr. Reddy’s Recalls Sapropterin Dihydrochloride
04/24/2024
 
 
TXT Pivya Approved for Uncomplicated UTIs
04/24/2024
 
 
TXT Priority Review for Jemperli sBLA
04/24/2024
 
 
TXT Boehringer on Improving Informed Consent Guide
04/24/2024
 
 
TXT Biological Promotion Q&A Guidance
04/24/2024
 
 
TXT State Lack of Fenofibrate CV Benefit: Petition
04/24/2024
 
 
TXT Get Involved with FDA on AI/ML: Attorneys
04/23/2024
 
 
TXT 23 No-Longer-Marketed NDAs Withdrawn
04/23/2024
 
 
TXT FDA Launches ‘Home as a Healthcare Hub’
04/23/2024
 
 
TXT New Bladder Cancer Therapy Approved
04/23/2024
 
 
TXT Sail Fusion Sacroiliac Fusion Device Cleared
04/23/2024
 
 
TXT Pediatric Brain Tumor Therapy Approved
04/23/2024
 
 
TXT QS, MDR Issues at Royal Philips China Plant
04/23/2024
 
 
TXT Annual Report on Postmarketing Requirements
04/23/2024
 
 
TXT PMRs and PMCs Generally on Schedule: FDA Report
04/23/2024
 
 
TXT Par Recalls 7 Treprostinil Lots
04/22/2024
 
 
TXT Exactech Recalls Equinoxe Shoulder Devices
04/22/2024
 
 
TXT FDA Warns on OTC Anti-choking Devices
04/22/2024
 
 
TXT Panel to Review Colon Cancer Blood Test
04/22/2024
 
 
TXT ‘Complete Response' on Abeona’s PZ-Cel BLA
04/22/2024
 
 
TXT PhRMA Wants More Feedback on Innovative Trials
04/19/2024
 
 
TXT Draeger Recalls Perseus Anesthesia Device
04/19/2024
 
 
TXT Boxed Warning Ordered on CAR T-Cell Therapies
04/19/2024
 
 
TXT Alvotech/Teva’s Stelara Biosimilar Approved
04/19/2024
 
 
TXT AdvaMed Seeks Clarification on Ethnicity Data in RWE
04/19/2024
 
 
TXT Rinvoq Shows Promise in Arteritis: AbbVie
04/18/2024
 
 
TXT Data Show Long-Term Shingrix Efficacy: GSK
04/18/2024
 
 
TXT Philips Respironics Recalls Trilogy Evo Ventilators
04/18/2024
 
 
TXT FDA Approves Lumisight to Help Find Cancer
04/18/2024
 
 
TXT New PMI Form Explained
04/18/2024
 
 
TXT SCOTUS Won’t Hear False Labeling Case
04/18/2024
 
 
TXT Woodcock Plays Advisory Role at Patient Nonprofit
04/18/2024
 
 
TXT PhRMA Changes for Data Committee Guide
04/18/2024
 
 
TXT 3rd Eugia FDA-483 This Year So Far
04/17/2024
 
 
TXT It’s Official: Oncopeptides’ Pepaxto is Withdrawn
04/17/2024
 
 
TXT FDA Denies Generic Imodium Petition
04/17/2024
 
 
TXT FDA Reports on Device Safety, Innovation
04/17/2024
 
 
TXT Sen. Cassidy Challenges FDA on CDS Oversight
04/17/2024
 
 
TXT Lilly Filing NDA for Expanded Tirzepatide Use
04/17/2024
 
 
TXT Restrictions on Lutathera ANDA Sought
04/17/2024
 
 
TXT Sun Pharma Hit With 483 After India Inspection
04/17/2024
 
 
TXT Soulaire Marketing Unapproved Device: FDA
04/16/2024
 
 
TXT 2 CGMP Violations in Natco Pharma Inspection
04/16/2024
 
 
TXT Clinical Trial Innovation Center Established
04/16/2024
 
 
TXT Ex-CEO Sentenced Over Phony Covid Test
04/16/2024
 
 
TXT FDA Warns on Suspected Counterfeit Botox
04/16/2024
 
 
TXT Xstim Spine Fusion Stimulator Approved
04/16/2024
 
 
TXT CBER Joining Lupus Research Consortium
04/16/2024
 
 
TXT C&T Dream Co. CGMP Violations
04/16/2024
 
 
TXT New CDRH Dataset for Chemical Characterization
04/16/2024
 
 
TXT Clinical Hold on Neumora Study in Brain Diseases
04/15/2024
 
 
TXT HeartMate Pumps Recalled Due to Obstructions
04/15/2024
 
 
TXT CDER Launches Trial Innovation Center
04/15/2024
 
 
TXT Novartis Reports Favorable Data on Kidney Drug
04/15/2024
 
 
TXT FDA Inspection Hits Zydus With Form-483
04/15/2024
 
 
TXT Fresenius Recalls Infusion Pump Software
04/12/2024
 
 
TXT Sun Gets OAI Inspection at India Facility
04/12/2024
 
 
TXT Panel Backs Minimal Residual Disease Endpoint
04/12/2024
 
 
TXT Enlivex Mixed Results of Sepsis Cell Therapy
04/12/2024
 
 
TXT PureTech Gets Fast Track on LYT-200
04/12/2024
 
 
TXT AI Software Authorized for Osteoporosis Screens
04/12/2024
 
 
TXT EMA Committee Dismisses GLP-1 Suicidality Risk
04/12/2024
 
 
TXT FDA Updates Safety Labeling for Envarsus XR
04/12/2024
 
 
TXT Oncolytics Wants FDA Meeting on Pelareorep
04/11/2024
 
 
TXT 6 Observations in Cipla FDA-483
04/11/2024
 
 
TXT Roche Alzheimer’s Test is Breakthrough Device
04/11/2024
 
 
TXT Neurovalens Anxiety Device Cleared
04/11/2024
 
 
TXT Drug Shortages at Highest Level: ASHP
04/11/2024
 
 
TXT Califf Defends FDA Role in Patent Listings
04/11/2024
 
 
TXT Appeals Court Upholds Norwich ANDA Delay
04/11/2024
 
 
TXT 9 Applicants Chosen for Drug Quality Evaluation
04/11/2024
 
 
TXT FDA Complex Innovative Designs Meeting Praised
04/10/2024
 
 
TXT FDA OKs CAR-T Trial in Children for Lupus
04/10/2024
 
 
TXT Army Scientific Group’s Hemorrhage AI Detector Cleared
04/10/2024
 
 
TXT Italfarmaco Awarded Priority Review Voucher
04/10/2024
 
 
TXT Par Sues FDA Over BPI Epinephrine Approval
04/10/2024
 
 
TXT ODAC to Discuss Minimal Residual Disease Endpoint
04/10/2024
 
 
TXT Include Pregnant, Lactating Women in Trials: Report
04/10/2024
 
 
TXT Import Alert Against China Syringe Maker
04/10/2024
 
 
TXT Methodological Rigor Info May Help Promotions: OPDP
04/09/2024
 
 
TXT Alkem Labs Hit With 10-item Form-483
04/09/2024
 
 
TXT Philips Respironics Consent Decree Approved
04/09/2024
 
 
TXT Multiple Violations at Kilitch Healthcare India
04/09/2024
 
 
TXT CGMP Violations in Jiangsu Meifan Records Review
04/09/2024
 
 
TXT No Benefit in Many Cancer Accelerated Approvals
04/09/2024
 
 
TXT BrainStorm Gets FDA Buy-In on Special Protocol
04/09/2024
 
 
TXT Antaria API Deviations Cited
04/09/2024
 
 
TXT Vanda Case Could Produce Legislation: Report
04/09/2024
 
 
TXT 10 FDA Advisors Had Financial Ties with Abbott: KFF
04/09/2024
 
 
TXT ViiV Wins Adolescent HIV Use for Dovato
04/08/2024
 
 
TXT Spirair Nasal Septal Deviation Device Cleared
04/08/2024
 
 
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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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  • Major news insights, follow-ups and reactions in each product area;
  • Summaries of the latest Warning Letters;
  • The newest product approvals;
  • Summaries of the latest FDA Federal Register notices;
  • Summaries of DDMAC letters;
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