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FDA-RELATED NEWS
 
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TXT Year-One Report on the Generic Drug Cluster
09/20/2022
 
 
TXT Vanda Agrees to Pay Over $11 Million in Off-label Suit
09/19/2022
 
 
TXT FDA Reminds on Endotracheal Tube Obstructions
09/16/2022
 
 
TXT HHS Outlines FDA Projects Under Biotech Initiative
09/16/2022
 
 
TXT Akorn Pays $7.9 Million to Resolve False Claims Suit
09/15/2022
 
 
TXT Top FDA-483, Warning Letter Observations
09/15/2022
 
 
TXT FDA Grants, Denies Catalyst Amifampridine Petition
09/15/2022
 
 
TXT Novartis Wants Restrictions on Entresto ANDAs
09/15/2022
 
 
TXT FDA Challenges Illicit Trade Workshop Attendees
09/15/2022
 
 
TXT Baxter Clearlink Solution Set Recall is Class 1
09/15/2022
 
 
TXT Advisors to Discuss Pulse Oximeter Accuracy
09/15/2022
 
 
TXT Elemental Impurities Guidance
09/15/2022
 
 
TXT FDA Rejects Hearing Aid Standardization
09/14/2022
 
 
TXT FDA Partnership on Rare Neurodegenerative Diseases
09/14/2022
 
 
TXT Bob Temple Gets New Title, Role Remains the Same
09/14/2022
 
 
TXT MAPP on SGEs Representing Sponsors Before FDA
09/14/2022
 
 
TXT Affirm Dismissal of Lexapro Case: WLF
09/14/2022
 
 
TXT 3 Observations on Aurobindo FDA-483
09/14/2022
 
 
TXT Texas Longhorn RX Producing Illegal Drugs: FDA
09/13/2022
 
 
TXT $2 Million FDA Grant to Marker Therapeutics
09/13/2022
 
 
TXT Preserve Access to Compounded Hormones: APC
09/13/2022
 
 
TXT ISCT Criticizes Ruling in Cell, Gene Therapy Case
09/13/2022
 
 
TXT FDA Report on Generic Drug Approval Cost Savings
09/13/2022
 
 
TXT FDA in Pistoia Alliance Working Group
09/13/2022
 
 
TXT User Fee Reauthorization Talks Continue
09/13/2022
 
 
TXT FDA Denies Petition on Colonoscopy Preparation
09/12/2022
 
 
TXT FDA Approves BMS Plaque Psoriasis Drug
09/12/2022
 
 
TXT Biomarin Reports Leukemia in Patient on Gene Therapy
09/12/2022
 
 
TXT Boston Imaging V7 Ultrasound Cleared
09/09/2022
 
 
TXT FDA Taps PATH’s Kaslow as Vaccine Chief
09/09/2022
 
 
TXT Pfizer NDA for Alopecia Drug Accepted for Review
09/09/2022
 
 
TXT RWD, RWE Submission Guidance
09/08/2022
 
 
TXT FDA Denies 2014 LASIK Petition
09/08/2022
 
 
TXT UCS Surveying State of Science Under Biden
09/08/2022
 
 
TXT FDA Breast Implant Cancer Alert
09/08/2022
 
 
TXT FDA Emergency Monkeypox Test Guidance
09/08/2022
 
 
TXT Panacea Biotec Inspection is OAI
09/08/2022
 
 
TXT Safety Alert on Abbott’s MitraClip Delivery Systems
09/08/2022
 
 
TXT Nonprescription Drug Label Guidance
09/08/2022
 
 
TXT 7 Observations in Korea’s Hugel FDA-483
09/07/2022
 
 
TXT Pharmacology Pediatric Studies Guidance
09/07/2022
 
 
TXT CDER, CBER Accept 1st ISTAND Submission
09/07/2022
 
 
TXT Stakeholders Want Changes to Supply Chain Guidance
09/07/2022
 
 
TXT Pacira Seeking Expanded Label on Exparel
09/07/2022
 
 
TXT FDA Lifts Hold on Sarepta Duchenne Drug Trial
09/06/2022
 
 
TXT Leaf of Life Marketing Illegal New Drugs: FDA
09/06/2022
 
 
TXT Boston Scientific’s Watchman Gets Revised Label
09/06/2022
 
 
TXT CDER Working to Optimize Drug Absorption
09/06/2022
 
 
TXT FDA Denies Most of Salix Xifaxin Petition
09/06/2022
 
 
TXT Bayer Paying $40 Million to Settle 2 Whistleblower Suits
09/06/2022
 
 
TXT Advancing Regulatory Science at FDA 2022 Report
09/06/2022
 
 
TXT FDA Approves Fresenius Kabi Biosimilar
09/06/2022
 
 
TXT FDA Approves Boehringer Pustular Psoriasis Drug
09/02/2022
 
 
TXT Imfinzi Approved for Biliary Tract Cancer
09/02/2022
 
 
TXT FDA Observations from 3 Biocon Biologics Inspections
09/01/2022
 
 
TXT Cue Health Seeks De Novo for At-Home Flu Test
09/01/2022
 
 
TXT GDUFA Research Supports Generic Drug Development
09/01/2022
 
 
TXT FDA, C-Path Exploring Lysosomal Diseases Group
09/01/2022
 
 
TXT Respironics Troubles Broaden as it Pays $24 Mil. Over False Claims
09/01/2022
 
 
TXT Integra CereLink Monitor Recall is Class 1
09/01/2022
 
 
TXT FDA’s ‘Whole-of-Government’ Approach to Illicit Products
09/01/2022
 
 
TXT Former Pharmatech CEO Gets 37 Months in Jail
09/01/2022
 
 
TXT Beam To Complete Clinical Hold Studies This Year
08/31/2022
 
 
TXT FDA OKs Genzyme’s Xenpozyme for ASMD
08/31/2022
 
 
TXT Changes Sought in Drug Shortage Draft Guidance
08/31/2022
 
 
TXT CGMP Violations at Green Wave Analytical
08/30/2022
 
 
TXT Priority Review for Sanofi’s Efanesoctocog Alfa
08/30/2022
 
 
TXT Device Cybersecurity Firm Hires Former FDA Reviewer
08/30/2022
 
 
TXT Multiple Violations at Elite One Source
08/30/2022
 
 
TXT Lessons Learned from PPI Case Studies
08/30/2022
 
 
TXT FDA Introduces Overdose Prevention Framework
08/30/2022
 
 
TXT Outlook Resubmits ONS-5010 BLA
08/30/2022
 
 
TXT Farxiga Phase 3 Data Show Mortality Benefit
08/29/2022
 
 
TXT 2 ICH Guidances on Drug Analytical Procedures
08/26/2022
 
 
TXT Medtronic HVAD Battery Recall is Class 1
08/25/2022
 
 
TXT Novartis Suspends Dosing in Branapalm Trial
08/25/2022
 
 
TXT CGMP Violations at Oregon’s Wild Harvest
08/25/2022
 
 
TXT Steps Toward Drug Quality Knowledge Management System
08/25/2022
 
 
TXT Positive Results in Pfizer RSV Vaccine Trial
08/25/2022
 
 
TXT FDA Approves Abbott Proclaim Plus System
08/25/2022
 
 
TXT FDA Releases 3 Drug Safety-Related Label Changes
08/24/2022
 
 
TXT House Committee on Trump's Covid Pressure on FDA
08/24/2022
 
 
TXT Amazon Warning Letter Raises Questions: Attorneys
08/24/2022
 
 
TXT Pull IPOL Polio Vaccine Until Better Trial Held: ICAN
08/24/2022
 
 
TXT GSK Opposes Teva Coreg ‘Skinny Label’ Appeal
08/23/2022
 
 
TXT Stakeholders Want More Drug Shortage Mitigation Info
08/23/2022
 
 
TXT Ways to Improve FDA Advisory Committee Process
08/23/2022
 
 
TXT FDA Updates eMDR System Enhancements
08/23/2022
 
 
TXT MDIC Somatic Reference Samples Initiative
08/23/2022
 
 
TXT Califf on FDA and the Clinical Community
08/23/2022
 
 
TXT Optical Lens Maker Pays $16.4 Million Over False Claims
08/23/2022
 
 
TXT CDER to Discuss Quality Management Maturity at Meeting
08/22/2022
 
 
TXT Draft Guide on Charging for Investigational Drugs
08/22/2022
 
 
TXT Koag Vascular Closure Pad Cleared
08/22/2022
 
 
TXT NIH’s Fauci Stepping Down At End of Year
08/22/2022
 
 
TXT Medtronic Defibrillator Recall is Class 1
08/19/2022
 
 
TXT FDA Cites Sun Pharma Over GMP Violations
08/19/2022
 
 
TXT Draft Guide on Contact Lens Care Labeling
08/18/2022
 
 
TXT FDA Lifts 1 Emavusertib Clinical Hold
08/18/2022
 
 
TXT FDA Approves Bayer Mirena sNDA
08/18/2022
 
 
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