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FDA-RELATED NEWS
 
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TXT Neurotris Illegally Marketing Devices: FDA
11/07/2023
 
 
TXT Real-Time Oncology Review Guidance
11/07/2023
 
 
TXT Bill Seeks to Shift Drug Making to U.S.
11/07/2023
 
 
TXT Covid Container Closure Guidance Still Effective
11/07/2023
 
 
TXT J&J Plans 2024 Surgery Robot IDE Trials
11/07/2023
 
 
TXT One-Third of BTD Requests Granted: Analysis
11/07/2023
 
 
TXT Orphan Status for Breast Cancer Radiotherapy
11/06/2023
 
 
TXT Guide on ‘Item Response Theory’ Clinical Data
11/06/2023
 
 
TXT Guide on Device Export Certifications
11/06/2023
 
 
TXT CDRH Endorses Device Cybersecurity Standard
11/06/2023
 
 
TXT Petition Seeks to Block Vigabatrin Exclusivity
11/06/2023
 
 
TXT Submitting PRO Data in Cancer Trials Guide
11/03/2023
 
 
TXT House Oversight Panel Probes Drug Shortages
11/03/2023
 
 
TXT Supernus Parkinson’s Off Episodes NDA Refiled
11/03/2023
 
 
TXT Empatica Adds 2 Biomarkers to Monitoring Device
11/03/2023
 
 
TXT FDA/Moderna ‘Revolving Door’ Analyzed
11/02/2023
 
 
TXT Lilly Sees Alzheimer’s Drug Decision Delay
11/02/2023
 
 
TXT Fix Pulse Oximeter Biases, 25 State AGs Tell FDA
11/02/2023
 
 
TXT FDA Seeking Diabetes DHT Info
11/02/2023
 
 
TXT FDA OKs Abbott HPV Diagnostic Test
11/02/2023
 
 
TXT Monoclonal Antibody Manufacturing Changes Research
11/02/2023
 
 
TXT I-Mab Gets Breakthrough for Nephropathy
11/02/2023
 
 
TXT House GOPers ‘Concerned’ About FDA Lab Safety
11/02/2023
 
 
TXT FDA Continues Device Supplement Guidance
11/01/2023
 
 
TXT Why Are FDA-483 Observations the Same?
11/01/2023
 
 
TXT Panel Backs Sickle Cell Gene Therapy Safety
11/01/2023
 
 
TXT FDA Expects Increasing Cannabis Research
11/01/2023
 
 
TXT Unlicensed Wholesaler Sentenced to Prison
11/01/2023
 
 
TXT Tonix Shuts Down Depression Drug Development
11/01/2023
 
 
TXT New FDA Off-Label Guide Has ‘Challenges’: Lawyers
11/01/2023
 
 
TXT FDA Sends 8-item 483 to NATCO Pharma
11/01/2023
 
 
TXT Multiple Violations at WAVi Co.
10/31/2023
 
 
TXT Stakeholders’ Views on FRAME
10/31/2023
 
 
TXT Clinical Hold Lifted on Mersana’s XMT-2056
10/31/2023
 
 
TXT Changes Sought to FDA’s IT Strategy
10/31/2023
 
 
TXT API CGMP Deviations at Ali Pharmaceutical
10/31/2023
 
 
TXT ‘Objectionable Conditions’ at BTS Research
10/31/2023
 
 
TXT FDA OKs Gene Therapy Trial for Heart Disease
10/31/2023
 
 
TXT AdvaMed Points ONCD to Cyber Harmonization
10/31/2023
 
 
TXT Amgen’s Interchangeable Stelara Biosimilar Approved
10/31/2023
 
 
TXT FDA Should Develop Vision PRO Tool: AdvaMed
10/30/2023
 
 
TXT FDA Warns on 26 Eye Drop Products
10/30/2023
 
 
TXT Sarepta Seeking Gene Therapy Expanded Use
10/30/2023
 
 
TXT GSK Jemperli Trial Meets Endpoint
10/30/2023
 
 
TXT Novartis Seeks Accelerated OK for IgAN Drug
10/30/2023
 
 
TXT Lilly’s Ulcerative Colitis Therapy Approved
10/27/2023
 
 
TXT TX Man Gets 5 Years Over Unapproved Drugs
10/27/2023
 
 
TXT Sickle Cell Therapy Safety Assessment Questioned
10/27/2023
 
 
TXT Bill to Reduce Dependence on China Drugs
10/27/2023
 
 
TXT Paige AI Lymph Node Gets Breakthrough
10/27/2023
 
 
TXT FDA Trims, Updates Biosimilars Labeling
10/26/2023
 
 
TXT Probiotics Can Hurt Hospitalized Preterm Infants: FDA
10/26/2023
 
 
TXT Positive Data on Pfizer/BioNTech Combo Vaccine
10/26/2023
 
 
TXT Olympus Recalls Insufflation Units
10/26/2023
 
 
TXT Breakthrough Device Changes Needed: Research
10/26/2023
 
 
TXT Qiagen, Myriad Partner on Cancer Diagnostics
10/26/2023
 
 
TXT Add Device Identifier to Medicare Forms: Senators
10/26/2023
 
 
TXT CDER Made ‘Erroneous Statements’ to A/C: Letter
10/25/2023
 
 
TXT Remote Interactive Evaluation Guidance
10/25/2023
 
 
TXT Medinol Gets OK on Latest Drug-Eluting Stent
10/25/2023
 
 
TXT FDA Decision on Florida Drug Imports Delayed: Report
10/25/2023
 
 
TXT Akebia Refiles Kidney Disease NDA
10/25/2023
 
 
TXT ‘Positive Results’ from BioXcel Data Audit
10/25/2023
 
 
TXT Califf Positive on Visit to India
10/25/2023
 
 
TXT Dermatologic Corticosteroid BE Guidance
10/25/2023
 
 
TXT FDA Approves New Tibsovo Indication
10/24/2023
 
 
TXT UCB Farchim FDA-483 Released
10/24/2023
 
 
TXT FDA Changes Off-Label Approach: Attorney
10/24/2023
 
 
TXT ResMed Recalls Astral 100, 150 Ventilators
10/24/2023
 
 
TXT FDA Accepts sBLA for Self-Administered FluMist
10/24/2023
 
 
TXT Predetermined Change Control Plan Principles
10/24/2023
 
 
TXT Embryll Marketing Unapproved Animal Drug: FDA
10/24/2023
 
 
TXT FDA Clears NKGen IND for Alzheimer’s Cell Therapy
10/24/2023
 
 
TXT Genentech’s Rozlytrek Gets Expanded Use
10/24/2023
 
 
TXT Guide on Scientific Info on Unapproved Uses
10/23/2023
 
 
TXT FDA Approves Zymfentra as Maintenance Therapy
10/23/2023
 
 
TXT Panacea Biotec Gets 9-item FDA-483
10/23/2023
 
 
TXT Complete Response on Dupixent sBLA
10/23/2023
 
 
TXT Medtronic Warning on McGrath Video Laryngoscopes
10/23/2023
 
 
TXT Keytruda ‘Positive’ Data in Cervical Cancer
10/20/2023
 
 
TXT Pfizer Pentavalent Meningococcal Vaccine Approved
10/20/2023
 
 
TXT Philips Respironics Recalls V60 Ventilators
10/20/2023
 
 
TXT Arrest Made in Misbranded Device Case
10/20/2023
 
 
TXT BioMarin Expanded Indication for Voxzogo
10/20/2023
 
 
TXT OCE Scientific Collaborative Research Areas
10/19/2023
 
 
TXT Final Guide on Remote Monitoring Devices
10/19/2023
 
 
TXT Hygienic Labs Didn’t Respond to FDA Data Requests
10/19/2023
 
 
TXT BMS Seeking Approval of Subcutaneous Opdivo
10/19/2023
 
 
TXT Confusion Exists in RWD/RWE Definitions: Analysis
10/19/2023
 
 
TXT Regenerative Medicine Consensus Standards Guide
10/19/2023
 
 
TXT FDA Updates AI/ML-Enabled Medical Device List
10/19/2023
 
 
TXT Untitled Letter for India’s Nectar Lifesciences
10/19/2023
 
 
TXT Guide on Drug, Biologic Benefit/Risk Assessment
10/18/2023
 
 
TXT SeaStar Breakthrough Status for Cytopheretic Device
10/18/2023
 
 
TXT Courts Could Cut FDA Labeling Enforcement: Avorn
10/18/2023
 
 
TXT FCA Cases Look at Cybersecurity: Attorneys
10/18/2023
 
 
TXT BrainStorm Pulls NurOwn BLA
10/18/2023
 
 
TXT Non-Invasive Monitoring Enforcement Guide
10/18/2023
 
 
TXT FDA Clears Intellia IND for Phase 3 Trial
10/18/2023
 
 
TXT Praxis 510(k) for Biopsy Device Cleared
10/17/2023
 
 
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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:
  • The latest agency policy developments, often before they're officially announced;
  • 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;
  • Related industry news capsules;
  • The industry's most concise FDA news index;
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