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FDA-RELATED NEWS
 
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TXT Guide on Neonatal Neurodevelopmental Safety Studies
10/18/2024
 
 
TXT Guide on ANDA Drug Master File Reviews
10/18/2024
 
 
TXT Gilead Pulls Trodelvy Urothelial Cancer Indications
10/18/2024
 
 
TXT Avadel Wins Expanded Label for Lumryz
10/18/2024
 
 
TXT Boston Scientific Recalls Obsidio Embolic Device
10/18/2024
 
 
TXT Neurodevelopmental Safety Studies in Neonatal Products
10/17/2024
 
 
TXT FDA Continues to Review Ocaliva sNDA
10/17/2024
 
 
TXT AbbVie NDA for Parkinson’s Drug Approved
10/17/2024
 
 
TXT Guide on Postoperative Nausea/Vomiting Drugs
10/17/2024
 
 
TXT FDA Wants Integrated Drug Review Feedback
10/17/2024
 
 
TXT Cancer Trial Core Patient-Reported Outcomes Guide
10/17/2024
 
 
TXT Guide on ANDA Reconsideration Requests
10/17/2024
 
 
TXT Staska Pharma Recalls Ascorbic Acid Solution
10/17/2024
 
 
TXT GSK NDA Accepted for New Antibiotic
10/16/2024
 
 
TXT FDA’s Central Role in AI Regulation
10/16/2024
 
 
TXT Guidance on Temp Policies for Drug Compounding
10/16/2024
 
 
TXT FDA Holds Novavax Covid/Flu Vaccine IND
10/16/2024
 
 
TXT GDUFA Division Level Reconsideration Request
10/16/2024
 
 
TXT Novocure’s Optune Lua for Lung Cancer OK’d
10/16/2024
 
 
TXT Court Tosses Novartis Entresto Suit Against FDA
10/16/2024
 
 
TXT FDA on Curbing X-ray Device Interference
10/15/2024
 
 
TXT CGMP Violations at Outin Futures
10/15/2024
 
 
TXT 14 Observations in Qualgen FDA-483
10/15/2024
 
 
TXT FDA Clears AI-Interpreting Echocardiography Software
10/15/2024
 
 
TXT Jazz Plans sNDA for Zepzelca in Lung Cancer
10/15/2024
 
 
TXT CDER, CBER Working on START Trial Support Program
10/15/2024
 
 
TXT CDER Drug Shortage Management Process
10/15/2024
 
 
TXT CDRH Pilots Trial Participation Snapshots
10/15/2024
 
 
TXT IDE for Implantable Underactive Bladder Implant
10/14/2024
 
 
TXT Endosseous Dental Implants Performance Criteria Guide
10/14/2024
 
 
TXT FDA Approves Intraocular Lens for Cataract Surgery
10/14/2024
 
 
TXT GSK Plans BLA for Nasal Polyp Therapy
10/14/2024
 
 
TXT FDA Clears Spectralis Imaging Module
10/14/2024
 
 
TXT Priority Voucher Used on Kisqali sNDA
10/14/2024
 
 
TXT PTC Therapeutics NDA for Treating Phenylketonuria
10/14/2024
 
 
TXT Rule on Device GMP Requirements Corrected
10/11/2024
 
 
TXT CDRH Web Page on Upcoming Guidances
10/11/2024
 
 
TXT FDA Seeks Drug Firms for Site Visitation Program
10/11/2024
 
 
TXT Guide on Compounding Drugs Affected by Hurricanes
10/11/2024
 
 
TXT Performance Criteria for Endosseous Dental Implants
10/11/2024
 
 
TXT FDA OKs Pfizer’s Hympavzi for Hemophilia A and B
10/11/2024
 
 
TXT Sanofi Scraps Phase 2 Multiple Sclerosis Study
10/11/2024
 
 
TXT Nanchang Anobri FDA-483 Released
10/10/2024
 
 
TXT Priority Voucher Used on Tremfya sBLA
10/10/2024
 
 
TXT Aqualex FDA-483 Has 6 Inspection Observations
10/10/2024
 
 
TXT Trial Planned for New Weight Loss Drug
10/10/2024
 
 
TXT CDRH Prioritized FY 2024 Guidance List
10/10/2024
 
 
TXT FDA Plans Pediatric Acetaminophen Safety Order
10/10/2024
 
 
TXT Medical Device Company Sentenced to Pay $42 Million
10/10/2024
 
 
TXT FDA Approves Genentech’s Itovebi Breast Cancer Drug
10/10/2024
 
 
TXT Implantable Bladder Stimulator Study Approved
10/10/2024
 
 
TXT Part 11 Final Guide has Broader Applicability: Attorneys
10/10/2024
 
 
TXT Teva Pays $450 Million to Settle Kickback Cases
10/10/2024
 
 
TXT IDE OK’d for Robotic Prostate Cancer Surgery
10/09/2024
 
 
TXT Zealand Hypoglycemia NDA Denied FDA Approval
10/09/2024
 
 
TXT Bayer Files NDA for Menopause Drug
10/09/2024
 
 
TXT FDA Exempts Some from Supply Chain Security Act
10/09/2024
 
 
TXT Do More to Prevent DSCSA Disruptions: Congress
10/09/2024
 
 
TXT Neuvivo Files NDA for Lou Gehrig’s Therapy
10/09/2024
 
 
TXT FDA New Alternative Methods Office Needed: Report
10/09/2024
 
 
TXT GSK Says Arexvy Protects Over Three RSV Seasons
10/09/2024
 
 
TXT 6 Baxter Products in Shortage Due to Hurricane: FDA
10/09/2024
 
 
TXT ‘Objectionable Conditions’ at LSU Institutional Review Board
10/08/2024
 
 
TXT FDA Releases Apitoria Pharma FDA-483
10/08/2024
 
 
TXT 8 Observations in Biocon FDA-483
10/08/2024
 
 
TXT House Wants FDA Briefing on Fake Ozempic
10/08/2024
 
 
TXT Sentec/Percussionaire Recalls Ventilator Valve
10/08/2024
 
 
TXT More Suicide Deaths Linked to FDA Antidepressant Warnings
10/08/2024
 
 
TXT FDA Questions Data in Stealth NDA for Barth Syndrome
10/08/2024
 
 
TXT Workshop Advances Brain/Computer Interface Assessment
10/08/2024
 
 
TXT Two Stakeholder Comments on BCG-Unresponsive Guide
10/08/2024
 
 
TXT Hospital Group Seeks FDA Actions in IV Solution Shortages
10/07/2024
 
 
TXT Woodcock Joins Board at Drug Repurposing Nonprofit
10/07/2024
 
 
TXT Respironics Recalls Trilogy Ventilators Over Nebulizers
10/07/2024
 
 
TXT Clinical Hold Slapped on Kezar Lupus Trial
10/07/2024
 
 
TXT Sublocade Priority Review for Expanded Labeling
10/07/2024
 
 
TXT AdvaMed Seeks FDA Best Practice on Trial Diversity
10/07/2024
 
 
TXT Medtronic Recalls MiniMed Pumps Over Batteries
10/04/2024
 
 
TXT FDA Clears PlaqueIQ for Cardiovascular Disease
10/04/2024
 
 
TXT Thermo Fisher Plant Scrutinized by FDA: Reuters
10/04/2024
 
 
TXT CDRH Portal Update Tracks PMA Submissions
10/04/2024
 
 
TXT Drug-Drug Interaction Assessments Lacking: FDA Research
10/04/2024
 
 
TXT J&J Discontinues Dengue Virus Antiviral Development
10/04/2024
 
 
TXT Tirzepatide Shortage ‘Resolved,’ FDA Says
10/03/2024
 
 
TXT FDA Lifts Hold on Myotonic Dystrophy Drug
10/03/2024
 
 
TXT 5 Observations on BSO FDA-483
10/03/2024
 
 
TXT 18 Potential Signals of Serious Risks/New Safety Info
10/03/2024
 
 
TXT Opdivo Approved for Resectable Lung Cancer
10/03/2024
 
 
TXT FDA Denies Amneal Levothyroxine Petition
10/03/2024
 
 
TXT OrthAlign’s Lantern Hip Handheld Naviation Cleared
10/03/2024
 
 
TXT Aldeyra Refiles NDA for Dry Eye Disease
10/03/2024
 
 
TXT Guide on Study E-Records/Signatures
10/02/2024
 
 
TXT FDA Fast Track for Volastra Ovarian Cancer Drug
10/02/2024
 
 
TXT Lab Groups Seek Summary Judgment in LDT Suit
10/02/2024
 
 
TXT Changes Sought in Device Essential Outputs Guide
10/02/2024
 
 
TXT Philips Respironics Software Correction Class 1: FDA
10/02/2024
 
 
TXT 7 Observations in Annovex Pharma FDA-483
10/02/2024
 
 
TXT Siemens PMA for 3D Mammography Platform OK’d
10/02/2024
 
 
TXT Should FDA Place Hold on Troubled Alzheimer’s Drug?
10/02/2024
 
 
TXT Cassidy Wants Info on Orange Book Listing Requirements
10/01/2024
 
 
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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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  • The newest product approvals;
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