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FDA-RELATED NEWS
 
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TXT Device Consensus Standards Modifications
06/24/2024
 
 
TXT Invega Not Withdrawn Due to Safety/Efficacy
06/24/2024
 
 
TXT Janssen’s TB Drug Converted to Full Approval
06/24/2024
 
 
TXT Small Entity Compliance Guide on LDT Phase-out
06/24/2024
 
 
TXT Endotronix Pulmonary Artery Sensor Approved
06/24/2024
 
 
TXT Committee Finds Troubling Foreign Inspection Issues
06/24/2024
 
 
TXT FDA Denies Petition Seeking Wakix Withdrawal
06/24/2024
 
 
TXT Lexicon Refiles NDA for Sotagliflozin
06/21/2024
 
 
TXT Déjà vu: Marks Overrides Reviewers on Duchenne Drug Again
06/21/2024
 
 
TXT Zoll Recalls Ventilators Over Operator Guides
06/21/2024
 
 
TXT Guide on Adulteration when Inspection Refused
06/21/2024
 
 
TXT Workshop on NDA/BLA Meeting Management Practices
06/21/2024
 
 
TXT Lilly’s Files Mounjara NDA for Sleep Apnea
06/21/2024
 
 
TXT Clinical Hold Lifted on Huntington’s Drug
06/20/2024
 
 
TXT FDA OKs ‘Major’ Yescarta, Tecartus REMS Changes
06/20/2024
 
 
TXT 4 Observations in Dr. Reddy’s Inspection
06/20/2024
 
 
TXT Inspection Delay, Denial, Limit, Refusal Guidance
06/20/2024
 
 
TXT FDA Abandoning Biosimilar Switching Studies
06/20/2024
 
 
TXT J&J Seeks Tremfya Crohn’s Indication
06/20/2024
 
 
TXT De Novo for Onkos Implant Antibacterial Coating
06/20/2024
 
 
TXT Synapse Labs Studies ‘Unacceptable’: FDA
06/20/2024
 
 
TXT Praise, Suggestions for RWE Studies Guidance
06/20/2024
 
 
TXT Clinical Hold on Zentalis Drug After 2 Deaths
06/18/2024
 
 
TXT Elixir Breakthrough Status for Coronary Bioadapter
06/18/2024
 
 
TXT Akili OTC App Cleared for ADHD
06/18/2024
 
 
TXT 2023 Trial Diversity Workshop Report
06/18/2024
 
 
TXT Animal Drug User Fee Educational Conference
06/18/2024
 
 
TXT Former Device Company CEO Gets 6 Years in Prison
06/18/2024
 
 
TXT FDA Asks Input on Non-Device Software Functions, Impacts
06/18/2024
 
 
TXT Protein Data Bank Aided 100% of Targeted Cancer Drugs: Study
06/18/2024
 
 
TXT Truqap Misses Endpoints in Breast Cancer Trial
06/18/2024
 
 
TXT FDA WEBVIEW CLOSED 6/19 FOR JUNETEENTH
06/18/2024
 
 
TXT Partial Hold on BioNTech/Medilink Trial
06/17/2024
 
 
TXT Keytruda/Chemo Approved for Endometrial Cancer
06/17/2024
 
 
TXT Guide on Diabetic Foot Infection Drugs
06/17/2024
 
 
TXT Generic Drug Facility Readiness Inspection Guide
06/17/2024
 
 
TXT Form 483 Issued to Chugai After Inspection
06/17/2024
 
 
TXT QA Practice for AI Devices is Priority: FDA
06/17/2024
 
 
TXT Takeda Soticlestat Studies Miss Primary Endpoints
06/17/2024
 
 
TXT Clin-Pharm Considerations for Oligonucleotides Guide
06/14/2024
 
 
TXT Teleflex/Arrow Recall Aortic Catheters
06/14/2024
 
 
TXT Getinge Recalls Vaporizer Sevoflurane Maquet Filling
06/14/2024
 
 
TXT Novavax Amends Covid Vaccine EUA
06/14/2024
 
 
TXT Guide on Diabetic Foot Infection Drugs
06/14/2024
 
 
TXT Amgen’s Blincyto Gets Expanded Leukemia Use
06/14/2024
 
 
TXT Pfizer Duchene Gene Therapy Fails Phase 3 Study
06/13/2024
 
 
TXT Emerging Drug Safety Technology Meeting Program
06/13/2024
 
 
TXT DSCSA Pilot Project Report Out
06/13/2024
 
 
TXT ICH M10 Bioanalytical Method Analysis Q&A Guidance
06/13/2024
 
 
TXT FDA Accelerated Approval for BMS’ Augtyro Cancer Drug
06/13/2024
 
 
TXT Megadyne Recalls Pediatric Return Electrodes
06/13/2024
 
 
TXT 3 Bayesian Examples Added to Demonstration Project
06/13/2024
 
 
TXT Supreme Court Rejects Mifepristone Lawsuit
06/13/2024
 
 
TXT FDA Revises Covid Vaccine Composition Recommendation
06/13/2024
 
 
TXT Submit Long Covid Drug as IND: FDA
06/12/2024
 
 
TXT 5 Teva ProAir Patents Ordered Out of Orange Book
06/12/2024
 
 
TXT FDA Platform Technology Designation Analyzed
06/12/2024
 
 
TXT Positive Results for Setrusumab in Bone Disease
06/12/2024
 
 
TXT FDA OKs Lilly’s Retevmo for Some Thyroid Cancers
06/12/2024
 
 
TXT Appropriators Slash FDA Budget by $450 Million
06/12/2024
 
 
TXT Getinge Clinical Decision Support Software Cleared
06/12/2024
 
 
TXT CGMP Violations at Malaysia’s TCT Neutraceuticals
06/11/2024
 
 
TXT Cosmetic Solutions CGMP, Unapproved Drug Violations
06/11/2024
 
 
TXT Drug QA Inspections Up 40%: Report
06/11/2024
 
 
TXT Upcoming CDRH eMDR Enhancements
06/11/2024
 
 
TXT Medline Recalls Sub-G Endotracheal Tube
06/11/2024
 
 
TXT Concerns With Alzheimer’s Drug Development Guidance
06/11/2024
 
 
TXT Women Underrepresented in Device Trials: Research
06/11/2024
 
 
TXT Ipsen Gains Accelerated OK for Iqirvo
06/11/2024
 
 
TXT Arthritis Advisory Panel Renewed for 2 Years
06/10/2024
 
 
TXT Emerging Drug Safety Technology Meeting Program
06/10/2024
 
 
TXT GSK’s Arexvy Gets Expanded Approval
06/10/2024
 
 
TXT FDA Clears 2 Abbott OTC Glucose Monitors
06/10/2024
 
 
TXT FDA Panel Backs Lilly’s Alzheimer’s Drug
06/10/2024
 
 
TXT Geron Myelodysplastic Syndromes NDA Approved
06/07/2024
 
 
TXT CDER Proposes to Deny Vanda Hetlioz sNDA
06/07/2024
 
 
TXT DePuy Synthes Gets 510(k) for Robotic Knee Device
06/07/2024
 
 
TXT Cipla Gets 1-item 483 After May Inspection
06/07/2024
 
 
TXT Moon Surgical’s Maestro Surgical Device Cleared
06/07/2024
 
 
TXT 236 Potential Drug Shortages Prevented in 2023: FDA
06/06/2024
 
 
TXT Replimune Plans RP1 BLA After Positive Trial Data
06/06/2024
 
 
TXT Agency Debars Sievert for 10 Years
06/06/2024
 
 
TXT FDA Reviewers Air Alzheimer’s Drug Issues
06/06/2024
 
 
TXT GAO Cites OTC Hearing Aid Issues
06/06/2024
 
 
TXT Reps Seek Info for ‘Next Generation Cures’
06/06/2024
 
 
TXT Workshop on AI Use in Drug/Biologic Development
06/06/2024
 
 
TXT Pediatric Orthopedic Device Innovation ‘Lags’: Research
06/06/2024
 
 
TXT FDA Places Hold on Biomea Diabetes Trials
06/06/2024
 
 
TXT BIMO Electronic Submission Format Guidance
06/05/2024
 
 
TXT Drug Shortages at Decade High, Last Longer: USP
06/05/2024
 
 
TXT Panel Backs JN.1 Variant-Targeted Covid Vaccine
06/05/2024
 
 
TXT Amgen: Positive Data on Uplizna in Ig G4 Disease
06/05/2024
 
 
TXT FDA Denies Nautilus Glove Reconsideration Request
06/05/2024
 
 
TXT Questions on Alzheimer’s Drug Draft Guidance
06/05/2024
 
 
TXT Medtronic Recalls Malfunctioning StealthStation Software
06/05/2024
 
 
TXT Trexo Robotics Illegally Marketing Devices: FDA
06/05/2024
 
 
TXT Info Collection on Device Recall Authority
06/04/2024
 
 
TXT FDA Promoting ‘Pragmatic Clinical Research’: Califf
06/04/2024
 
 
TXT BMS Reports Positive Opdivo plus Yervoy Data
06/04/2024
 
 
TXT Multiple QS Issues in Techlem Inspection
06/04/2024
 
 
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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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