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FDA-RELATED NEWS
 
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TXT CDER Launches Quantitative Medicine Center
05/06/2024
 
 
TXT FDA Clears ZygoFix Spinal Fusion Alternative
05/06/2024
 
 
TXT WSJ ‘Apologizes’ for Supporting Califf
05/03/2024
 
 
TXT Dupixent COPD sBLA May Face Review Delay
05/03/2024
 
 
TXT Bill to Restrict Revolving Door When FDAers Depart
05/03/2024
 
 
TXT Inspections Reviewing More Promo Materials: Law Firm
05/03/2024
 
 
TXT Eugia Pharma Gets Fourth FDA-483 in 2024
05/03/2024
 
 
TXT Q-Submission Guide ‘Step in the Wrong Direction’: Expert
05/02/2024
 
 
TXT Office of Translational Sciences Annual Report
05/02/2024
 
 
TXT Mass Spectrometry Guide for Animal Drugs
05/02/2024
 
 
TXT Bill to Ban Tianeptine as a Supplement
05/02/2024
 
 
TXT Thoratec Recalls HeartMate 3 and LVAS Implant Kit
05/02/2024
 
 
TXT Apple Watch Qualified for AFib Trial Monitoring
05/02/2024
 
 
TXT Praise, Suggestions for Informed Consent Guide
05/02/2024
 
 
TXT Decentralized Trials’ Time Has Come: Marks
05/02/2024
 
 
TXT NCPA Statement to FDA Compounding Session
05/01/2024
 
 
TXT Use Accelerated Approval for Rare Diseases: Commentary
05/01/2024
 
 
TXT Finalize Race, Ethnicity Data Guidance: DFA
05/01/2024
 
 
TXT Multiple Violations at Indonesia’s P.T. Sankei
05/01/2024
 
 
TXT FDA Clears Hybrid Sacroiliac Joint Implant
05/01/2024
 
 
TXT Update Informed Consent Guidance: AdvaMed
05/01/2024
 
 
TXT High-Concentration Humira Biosimilar OK’d
05/01/2024
 
 
TXT Multiple Pinnacle BioLabs Violations Seen
04/30/2024
 
 
TXT QS, MDR Violations at Future Diagnostics
04/30/2024
 
 
TXT FTC Expands ‘Junk’ Patent Challenges
04/30/2024
 
 
TXT Thiopurine Alert on Intrahepatic Cholestasis of Pregnancy
04/30/2024
 
 
TXT Pfizer Gets Traditional Approval for Tivdak
04/30/2024
 
 
TXT Listening Session on Advisory Committee Revamp
04/30/2024
 
 
TXT QS Violations in Unapproved Spectrum Devices
04/30/2024
 
 
TXT VITEK 2 Antimicrobial Test Cards Recalled
04/30/2024
 
 
TXT SonarMed Recalls Airway Sensors
04/29/2024
 
 
TXT Panel to Review Novo Nordisk’s Insulin Icodec
04/29/2024
 
 
TXT Human Allogeneic Cell Safety Testing Guide
04/29/2024
 
 
TXT X4 Pharma Gains Xolremdi Approval
04/29/2024
 
 
TXT Guide on Composition and Ingredient Statements
04/29/2024
 
 
TXT Listening Session on Improving Advisory Committees
04/29/2024
 
 
TXT 4-Year Enforcement Discretion for LDTs: Final Rule
04/29/2024
 
 
TXT Human/Animal Materials in Cell/Gene Therapies Guide
04/29/2024
 
 
TXT Marks Outlines CBER 2024 Top Priorities
04/26/2024
 
 
TXT Elekta Recalls Disposable Biopsy Needles
04/26/2024
 
 
TXT Pfizer Hemophilia B Gene Therapy Approved
04/26/2024
 
 
TXT Draft Guide on Drug Composition Statements
04/26/2024
 
 
TXT Roivios Gets Breakthrough Status on Renal Assist
04/26/2024
 
 
TXT Medtronic Spinal Cord Stimulator OK’d
04/26/2024
 
 
TXT FDA Fast Track for Compass Biliary Tract Cancer Drug
04/25/2024
 
 
TXT Cancer Trial Eligibility Criteria Guidance
04/25/2024
 
 
TXT FDA Tightening ‘Research Use Only’ Tests: Lawyers
04/25/2024
 
 
TXT Fresenius Recalls Stay-Safe Catheter Sets
04/25/2024
 
 
TXT Cancer Trial Performance Status Eligibility Criteria
04/25/2024
 
 
TXT Laboratory Values Cancer Trial Eligibility Criteria
04/25/2024
 
 
TXT Cardinal Health Monoject Inspection Violations
04/25/2024
 
 
TXT InfuTronix Recalls Malfunctioning Infusion Pumps
04/25/2024
 
 
TXT Cut Ozempic/Wegovy Price: HELP Committee
04/24/2024
 
 
TXT Curio Postpartum Depression Device Cleared
04/24/2024
 
 
TXT Zydus Lifesciences Issued Another FDA-483
04/24/2024
 
 
TXT Dr. Reddy’s Recalls Sapropterin Dihydrochloride
04/24/2024
 
 
TXT Pivya Approved for Uncomplicated UTIs
04/24/2024
 
 
TXT Priority Review for Jemperli sBLA
04/24/2024
 
 
TXT Boehringer on Improving Informed Consent Guide
04/24/2024
 
 
TXT Biological Promotion Q&A Guidance
04/24/2024
 
 
TXT State Lack of Fenofibrate CV Benefit: Petition
04/24/2024
 
 
TXT Get Involved with FDA on AI/ML: Attorneys
04/23/2024
 
 
TXT 23 No-Longer-Marketed NDAs Withdrawn
04/23/2024
 
 
TXT FDA Launches ‘Home as a Healthcare Hub’
04/23/2024
 
 
TXT New Bladder Cancer Therapy Approved
04/23/2024
 
 
TXT Sail Fusion Sacroiliac Fusion Device Cleared
04/23/2024
 
 
TXT Pediatric Brain Tumor Therapy Approved
04/23/2024
 
 
TXT QS, MDR Issues at Royal Philips China Plant
04/23/2024
 
 
TXT Annual Report on Postmarketing Requirements
04/23/2024
 
 
TXT PMRs and PMCs Generally on Schedule: FDA Report
04/23/2024
 
 
TXT Par Recalls 7 Treprostinil Lots
04/22/2024
 
 
TXT Exactech Recalls Equinoxe Shoulder Devices
04/22/2024
 
 
TXT FDA Warns on OTC Anti-choking Devices
04/22/2024
 
 
TXT Panel to Review Colon Cancer Blood Test
04/22/2024
 
 
TXT ‘Complete Response' on Abeona’s PZ-Cel BLA
04/22/2024
 
 
TXT PhRMA Wants More Feedback on Innovative Trials
04/19/2024
 
 
TXT Draeger Recalls Perseus Anesthesia Device
04/19/2024
 
 
TXT Boxed Warning Ordered on CAR T-Cell Therapies
04/19/2024
 
 
TXT Alvotech/Teva’s Stelara Biosimilar Approved
04/19/2024
 
 
TXT AdvaMed Seeks Clarification on Ethnicity Data in RWE
04/19/2024
 
 
TXT Rinvoq Shows Promise in Arteritis: AbbVie
04/18/2024
 
 
TXT Data Show Long-Term Shingrix Efficacy: GSK
04/18/2024
 
 
TXT Philips Respironics Recalls Trilogy Evo Ventilators
04/18/2024
 
 
TXT FDA Approves Lumisight to Help Find Cancer
04/18/2024
 
 
TXT New PMI Form Explained
04/18/2024
 
 
TXT SCOTUS Won’t Hear False Labeling Case
04/18/2024
 
 
TXT Woodcock Plays Advisory Role at Patient Nonprofit
04/18/2024
 
 
TXT PhRMA Changes for Data Committee Guide
04/18/2024
 
 
TXT 3rd Eugia FDA-483 This Year So Far
04/17/2024
 
 
TXT It’s Official: Oncopeptides’ Pepaxto is Withdrawn
04/17/2024
 
 
TXT FDA Denies Generic Imodium Petition
04/17/2024
 
 
TXT FDA Reports on Device Safety, Innovation
04/17/2024
 
 
TXT Sen. Cassidy Challenges FDA on CDS Oversight
04/17/2024
 
 
TXT Lilly Filing NDA for Expanded Tirzepatide Use
04/17/2024
 
 
TXT Restrictions on Lutathera ANDA Sought
04/17/2024
 
 
TXT Sun Pharma Hit With 483 After India Inspection
04/17/2024
 
 
TXT Soulaire Marketing Unapproved Device: FDA
04/16/2024
 
 
TXT 2 CGMP Violations in Natco Pharma Inspection
04/16/2024
 
 
TXT Clinical Trial Innovation Center Established
04/16/2024
 
 
TXT Ex-CEO Sentenced Over Phony Covid Test
04/16/2024
 
 
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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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