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FDA-RELATED NEWS
 
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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
 
 
TXT Keytruda OK’d Before/After Lung Cancer Surgery
10/17/2023
 
 
TXT ‘Is Chevron Deference Dead?’: Ex-FDAer Pitts
10/17/2023
 
 
TXT Guilty Plea in SphenoCath Case
10/17/2023
 
 
TXT FDA Wants Comments on Innovative Clinical Trials
10/17/2023
 
 
TXT Verrica Asks FDA to End Ycanth Compounding
10/17/2023
 
 
TXT 6 Observations in Samsung Biologics FDA-483
10/17/2023
 
 
TXT FDA Denies UCB Generic Fintepla Petition
10/17/2023
 
 
TXT Omeros Discontinues Narsoplimab Development
10/16/2023
 
 
TXT Skyrizi Better Than Stelara: AbbVie Data
10/16/2023
 
 
TXT Guide on Testing Pharmaceutical Alcohols
10/16/2023
 
 
TXT Guidance on Diabetic Foot Infection Drugs
10/16/2023
 
 
TXT Aldeyra Tussles With FDA on NDA Data
10/16/2023
 
 
TXT GE HealthCare Update on Neonatal Incubators
10/16/2023
 
 
TXT Priority Review for Tagrisso sNDA in Lung Cancer
10/16/2023
 
 
TXT Device Inspection Compliance Program Revised
10/13/2023
 
 
TXT Hogan Lovells Skeptical of New Generics Pilot
10/13/2023
 
 
TXT FDA OKs Pfizer Ulcerative Colitis Drug
10/13/2023
 
 
TXT InfoBionic Next-Gen Cardiac Monitor
10/13/2023
 
 
TXT FDA to Study Adherence Effect on Promotion
10/12/2023
 
 
TXT Topical Ophthalmic Drug Quality Guidance
10/12/2023
 
 
TXT Stelara Biosimilar Gets ‘Complete Response’
10/12/2023
 
 
TXT Info Collection on Regulatory Misconduct Allegations
10/12/2023
 
 
TXT 3 Stakeholder Comments on FDA QTc Guidance
10/12/2023
 
 
TXT 14 House Dems Want ADHD Drug Shortage Info
10/12/2023
 
 
TXT Fast Track for Glioblastoma Vaccine
10/12/2023
 
 
TXT FDA Sets Digital Health Technologies A/C
10/11/2023
 
 
TXT Cell, Gene Therapy Success Rates Analyzed
10/11/2023
 
 
TXT Breakthrough Devices Could Aid Disadvantaged: Attorneys
10/11/2023
 
 
TXT Senator Calls on FDA to Probe Respironics
10/11/2023
 
 
TXT Former FDAer Beitz Joins Law Firm
10/11/2023
 
 
TXT FDA Needs to Define ‘Substantial Equivalence’
10/11/2023
 
 
TXT Ozempic Kidney Study Stopped Due to Efficacy Data
10/11/2023
 
 
TXT No Care Access Issues in VALOR Trial: Company
10/11/2023
 
 
TXT Cytoxan Not Withdrawn Over Safety/Efficacy
10/11/2023
 
 
TXT Multiple Violations in Abiomed Inspection
10/10/2023
 
 
TXT 2 Unapproved GLP-1 Drug Marketers Warned: FDA
10/10/2023
 
 
TXT Suggested Changes to ‘Underrepresented’ Draft Guide
10/10/2023
 
 
TXT ‘Minor Updates’ to 2 Magnetic Resonance Guidances
10/10/2023
 
 
TXT Researcher Cited for ‘Objectionable Conditions’
10/10/2023
 
 
TXT FDA Cautions About Compounded Ketamine
10/10/2023
 
 
TXT FDA QTc Draft Guidance ‘Too Vague’: NCHR
10/10/2023
 
 
TXT CDRH Plans 24 Guidances in FY 2024
10/10/2023
 
 
TXT FDA Diversity Plan Draft Guidance Due: RAPS
10/10/2023
 
 
TXT Positive Keytruda Data in Lung Cancer: Merck
10/10/2023
 
 
TXT Companion Diagnostic for Retevmo Approved
10/09/2023
 
 
TXT Alnylam Gets ‘Complete Response’ on sNDA
10/09/2023
 
 
TXT Biocon Gets Insulin Aspart BLA Rejection
10/09/2023
 
 
TXT ‘Breakthrough’ Status for Knee Implant
10/09/2023
 
 
TXT 11 Dr. Reddy’s ANDAs Withdrawn
10/09/2023
 
 
TXT HistoSonics De Novo for Tumor Blaster
10/09/2023
 
 
TXT AstraZeneca Seeks More Input on Study Diversity
10/09/2023
 
 
TXT Sun Pharma NDA for Alopecia Areata
10/06/2023
 
 
TXT 2 Covid-19 Product EUAs Revoked
10/06/2023
 
 
TXT Senator Urges Justice Probe of Respironics
10/06/2023
 
 
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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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