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FDA-RELATED NEWS
 
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TXT Need for Device Transparency Seen in Celect Case
11/21/2024
 
 
TXT Draeger Atlan Recall is Class 1
11/20/2024
 
 
TXT Third-Party Review Guidance
11/20/2024
 
 
TXT New DTC Major Statement Standards Become Effective
11/20/2024
 
 
TXT Preserve Covid-19 Vaccine Records: Senator
11/20/2024
 
 
TXT CDER Deputy Throckmorton Retiring in January
11/20/2024
 
 
TXT PCCP Draft Guidance Stakeholder Recommendations
11/20/2024
 
 
TXT Fludarabine Phosphate Labeling Changes OKd
11/20/2024
 
 
TXT FDA Clears Ultromics EchoGo Amyloidosis Device
11/20/2024
 
 
TXT Sage Ending Dalzanemdor Development
11/20/2024
 
 
TXT FDA Warns Unexo Lifesciences Over CGMP
11/19/2024
 
 
TXT FDA Finds CGMP Violations in Originitalia Inspection
11/19/2024
 
 
TXT Put Semaglutide Drugs on DDC Lists: Novo Nordisk
11/19/2024
 
 
TXT CGMP Violations at Silliker Contract Lab
11/19/2024
 
 
TXT Tom’s of Maine CGMP Issues
11/19/2024
 
 
TXT Advisors Asked About Generative AI Regulation
11/19/2024
 
 
TXT Astellas Gets ‘Complete Response’ on Izervay sNDA
11/19/2024
 
 
TXT Stakeholder Comments on Oncology Trial Guidance
11/19/2024
 
 
TXT Panel Input Sought on Andexxa’s Thrombosis Risk
11/19/2024
 
 
TXT GSK Liver Disease Anti-Itch Drug Meets Endpoint
11/19/2024
 
 
TXT Cell/Gene Therapy Guide on Common Questions
11/18/2024
 
 
TXT Aldeyra Dry Eye NDA Accepted for Review
11/18/2024
 
 
TXT BrightHeart AI Review of Heart Ultrasounds Cleared
11/18/2024
 
 
TXT Takeda Slapped with 4-Item FDA-483
11/18/2024
 
 
TXT Martinez Permanently Debarred Over Trial Data
11/18/2024
 
 
TXT GAO Report Urges Key Strategies for FDA Rare Disease Efforts
11/18/2024
 
 
TXT Alert on VasoView Vessel Harvesting Devices
11/15/2024
 
 
TXT Phase 3 Eye Study Terminated After Data Review
11/15/2024
 
 
TXT FDA OKs Syndax Pharm Leukemia Drug
11/15/2024
 
 
TXT RFK Jr. Aims to ‘Free FDA from Corporate Capture’
11/15/2024
 
 
TXT Dupixent Supplemental BLA Filed for Urticaria
11/15/2024
 
 
TXT More Than 1,000 Breakthrough Device Designations
11/14/2024
 
 
TXT FDA Approves PTC Therapeutics’ Kebilidi
11/14/2024
 
 
TXT Medical Device Recalls Up, Drugs Down: Sedgwick
11/14/2024
 
 
TXT SonoMotion De Novo for Stone Clear Ultrasound
11/14/2024
 
 
TXT ‘False or Misleading’ Xeomin Promotion: FDA
11/14/2024
 
 
TXT Innovative Manufacturing Technologies Comments
11/14/2024
 
 
TXT Trump Taps RFK Jr. as HHS Secretary
11/14/2024
 
 
TXT Boston Scientific Recalls Cryoablation Catheters
11/13/2024
 
 
TXT LivaNova Sleep Apnea Device Meets Endpoints
11/13/2024
 
 
TXT FDA Needs Inspection Staff Recruitment Plan: GAO
11/13/2024
 
 
TXT Require Studies for Prednisolone Eye Drops: DifGen
11/13/2024
 
 
TXT Adaptimmune Therapeutics Plan Lete-Cel BLA
11/13/2024
 
 
TXT 7 Observations on U.S. Specialty FDA-483
11/13/2024
 
 
TXT Oligonucleotide-Based Therapeutic Assessment
11/13/2024
 
 
TXT SCOTUS Decisions’ Effect on FDA Analyzed
11/13/2024
 
 
TXT QS Issues at American Contract
11/12/2024
 
 
TXT CGMP Violations in Zhejiang Qimei Records Review
11/12/2024
 
 
TXT House Republicans Want GAO Lab Safety Review
11/12/2024
 
 
TXT FDA Warns Taiwanese, Australian X-ray Firms
11/12/2024
 
 
TXT Complete Response Letter on Ocaliva sNDA
11/12/2024
 
 
TXT Disappointed Califf on Possible Disruption at FDA
11/12/2024
 
 
TXT Lilly Opposes Tirzepatide Bulks List Nomination
11/12/2024
 
 
TXT Clinical Hold on Novavax Vaccines Lifted
11/11/2024
 
 
TXT Safety Issue Prompts Zelnecirnon Termination
11/11/2024
 
 
TXT J&J’s Nipocalimab Gets Breakthrough Status
11/11/2024
 
 
TXT Disappointing Data in Schizophrenia Drug: AbbVie
11/11/2024
 
 
TXT Brookfield Medical Hit with GMP Untitled Letter
11/11/2024
 
 
TXT FDA Clears Vertiwedge Intraosseous Device
11/11/2024
 
 
TXT Group Criticizes FDA Foot Dragging on Phenylephrine
11/08/2024
 
 
TXT Neurotech Review Extension on Retinal Disease BLA
11/08/2024
 
 
TXT Darxalex Faspro sBLA for Smoldering Multiple Myeloma
11/08/2024
 
 
TXT Bayer’s Medrad Centargo CT Injection Cleared
11/08/2024
 
 
TXT Allogene Reports Encouraging CAR-T Therapy Data
11/08/2024
 
 
TXT IRB Violations Seen in FDA-483s
11/07/2024
 
 
TXT Public Citizen Blasts Potential Drug Approval Change
11/07/2024
 
 
TXT FDA Ban on Phenylephrine in Nasal Decongestants
11/07/2024
 
 
TXT Poor Training Found in Lab Inspections
11/07/2024
 
 
TXT FDA Approves J&J Varipulse Platform
11/07/2024
 
 
TXT Sarepta Scraps Next-Gen Duchenne Drug
11/07/2024
 
 
TXT Model-Informed Drug Development Comments
11/07/2024
 
 
TXT Electa Instrument Recalls Biopsy Needle Kits
11/07/2024
 
 
TXT How Soon Will Trump Nominate Next FDA Head?
11/07/2024
 
 
TXT 9 Observations in Staska Pharmaceuticals FDA-483
11/06/2024
 
 
TXT Clozapine REMS Curbs Treatment: Comments
11/06/2024
 
 
TXT FDA OKs LumiThera Dry AMD Treatment
11/06/2024
 
 
TXT Caris’ Companion Diagnostic for Cancer Approved
11/06/2024
 
 
TXT ACLA Views on PCCP Draft Guidance
11/06/2024
 
 
TXT RFK Jr. Says Some FDA Departments Have to Go
11/06/2024
 
 
TXT Breakthrough Designation for SeaStar Dialysis Device
11/06/2024
 
 
TXT Extended Review for Organon’s Vtama sNDA
11/05/2024
 
 
TXT ‘Objectionable Conditions’ at Hospital IRB
11/05/2024
 
 
TXT FDA Can’t Regulate AI on its Own: Califf
11/05/2024
 
 
TXT FDA OKs Envoy Medical Cochlear Implant Study
11/05/2024
 
 
TXT CGMP Issues at China’s Shandong Boyuan
11/05/2024
 
 
TXT Analytical Food Laboratories CGMP Violations
11/05/2024
 
 
TXT Merus Zeno BLA Gets 3 Month Review Extension
11/05/2024
 
 
TXT Support, Suggestions for FDA Rare Disease Hub
11/05/2024
 
 
TXT Lawyer Says Not Enough FDA Digital Health Standards
11/05/2024
 
 
TXT Pilot Evaluating Quicker Reviews for Some Drugs
11/04/2024
 
 
TXT Clinical Holds Lifted on 3 CARsgen Cell Products
11/04/2024
 
 
TXT Phase 3 Study on Disc Medicine’s Bitopertin
11/04/2024
 
 
TXT Quanta Dialysis Home Dialysis Device Cleared
11/04/2024
 
 
TXT Mark Cuban’s Generic Operation Hit with 483
11/04/2024
 
 
TXT Ionis NDA for Hereditary Angioedema Attacks
11/04/2024
 
 
TXT Journey Rosacea Drug Approved by FDA
11/04/2024
 
 
TXT Percussionaire Recalls Breathing Circuits
11/01/2024
 
 
TXT FDA Taps Comstock Rick for Rare Disease Hub
11/01/2024
 
 
TXT Aarti Drugs India Plant Hit with FDA-483
11/01/2024
 
 
TXT Sen. Rubio Seeks to Ban Certain APIs from China
11/01/2024
 
 
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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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