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Regeneron Responding to Eylea ‘Complete Response’ 08/03/2023

RenatiLabs Illegally Marketing WJMAX 08/02/2023

FDA Warns Centaur on CGMP Issues 08/02/2023

Advancing RWE Program Deadline Coming 08/02/2023

PEPFAR Antiretroviral Drug Guidance 08/02/2023

Broader Scientific Topics for Advisory Panels: Bumpus 08/02/2023

Decentralized Clinical Trial Comments 08/02/2023

Baxter Recalls SIGMA Infusion Pumps 08/01/2023

FDA Fast Tracks Invectys IVS-3001 08/01/2023

Lupin Recalls 2 Lots of Tydemy Contraceptive 08/01/2023

FDA, DEA Steps to Ease Rx Stimulant Shortage 08/01/2023

FDA Warns Intas About Multiple Violations 08/01/2023

Iso-Tex Diagnostics CGMP Issues 08/01/2023

CGMP Violations at Baxter India Facility 08/01/2023

Teleflex QuikClot Device Expanded Use Cleared 08/01/2023

GSK Wins Expanded Use for Jemperli 07/31/2023

Senate Bill Introduced on Drug Shortages 07/31/2023

FDA Expands Device TAP Pilot 07/31/2023

Citius Pharma Gets Complete Response Letter 07/31/2023

Abbott Withdraws Trifecta Heart Valves 07/31/2023

GE Recalls TruSignal SpO2 Sensors 07/28/2023

FDA, Switzerland Recognizing Each Other's Inspections 07/28/2023

FDA, EMA Collaborate on Post-Approval Changes 07/28/2023

FDA Not Yet Implementing OTC Drug Reforms: GAO 07/28/2023

Opioid Disorder Innovative Devices 07/27/2023

Compliance Woes at Wegovy Syringe Plant 07/27/2023

FDA Won’t Review Toriluzole NDA 07/27/2023

RFK, Jr. for FDA or CDC: DeSantis 07/27/2023

Drug Shortage Legislative Fix Introduced 07/27/2023

Merck Pneumococcal Vaccine Hits Phase 3 Marks 07/27/2023

House Delays FDA Budget Floor Vote 07/27/2023

UltraSight Ultrasound Guidance Software Cleared 07/27/2023

Fentanyl Detection Kit Gains Clearance 07/26/2023

Alert Update on Vessel Occlusion CADt Devices 07/26/2023

Panel to Review BrainStorm ALS Submission 07/26/2023

Integrating ORA in Centers Has Risks: Analysis 07/26/2023

Recall Unapproved Phenobarb Products: Sun 07/26/2023

Central Admixture FDA-483 07/26/2023

FDA Hits Medical Device ‘Intended Use Creep’ 07/26/2023

Voluntary Consensus Standards Guidance 07/26/2023

Abbott Recalls Amplatzer Delivery Sheath 07/26/2023

Defender Pharma NDA for Scopolamine Gel 07/26/2023

Beckman Coulter Chemistry Analyzer Cleared 07/25/2023

Stratus Illegally Marketing Biologics: FDA 07/25/2023

FDA Denies 2 Vanda Tasimelteon Petitions 07/25/2023

CDRH Adds Device Sterilization Standards 07/25/2023

FDA Expanding CURE ID 07/25/2023

12 Catalent Inspection Observations 07/25/2023

FDA Told: ‘Generally Accepted’ Often Isn’t 07/25/2023

Dismissal Sought in FDA-483 Anonymity Suit 07/25/2023

3rd Circuit Flunks FDA Again Over Illegal Generics 07/25/2023

FDA Downplays Impact After Pfizer Tornado 07/24/2023

ICH Mutagenic Impurities Drug Guidance 07/24/2023

FDA Spending Bill Will See Veto: White House 07/24/2023

Horizon Misses on Lupus Phase 2 Endpoint 07/24/2023

Nesa Medtech Fibroid Mapping App Cleared 07/24/2023

FDA OKs Verrica NDA for Molluscum Topical 07/24/2023

ADC Therapeutics Discontinues Phase 2 Trial 07/21/2023

Bufferin NDA Withdrawn by FDA 07/21/2023

FDA OKs Emergent’s Anthrax Vaccine 07/21/2023

Peter Stoll Guilty on Medical Device Felony Count 07/21/2023

BIO Backs Rare Disease Endpoint Pilot 07/21/2023

FDA Clears BD Alaris Pump Troubles 07/21/2023

Wuxi Pharmaceutical FDA-483 07/20/2023

Abiomed Recalls All Lots of 6 Heart Pumps 07/20/2023

Vir Flu Vaccine Fails Phase 2 Trial 07/20/2023

Dismiss Norwich Rifaximin Suit: FDA 07/20/2023

MediView Surgical Augmented Reality Device Cleared 07/20/2023

Using ctDNA as an Early Endpoint 07/20/2023

FDA Monitoring Drug Shortages After Pfizer Tornado 07/20/2023

FDA OKs Vanflyta for Leukemia 07/20/2023

New FDA Tools in Democrats’ Preparedness Bill 07/19/2023

Don’t Use Quidel Triage Cardiac Panel: FDA 07/19/2023

Ex-FDA Gene Therapy Guru Joins Greenleaf 07/19/2023

8 Repeat QS Violations at Edge Biologicals 07/19/2023

Ambrx Gets Fast Track for Prostate Cancer Drug 07/19/2023

FDA Clears ReddyPort Ventilation Device 07/19/2023

4 Observations in SCA Pharmaceuticals FDA-483 07/19/2023

Keytruda Hits Endpoint in Cervical Cancer Trial 07/19/2023

FDA Clears Xstrahl Skin Cancer Radiation Therapy 07/19/2023

FDA Grants Fast Track for Myelofibrosis Drug 07/19/2023

CGMP Deviations at Centaur Pharmaceuticals 07/18/2023

Outset Medical Illegally Marketing Tablo System: FDA 07/18/2023

FDA Boosts Translational Sciences ‘Achievements’ 07/18/2023

Legislators Hit FDA's India, China Inspections 07/18/2023

Akebia Resubmitting Kidney Disease NDA 07/18/2023

Medtronic Recalls Faulty Defibrillators 07/18/2023

Suggestions for Pediatric Drug Guidance 07/18/2023

GAO Regenerative Medicine Policy Options 07/18/2023

Catalent Indiana Facility Cited in Form-483 07/17/2023

Quidel Cardio Recalls Cardiac Panel Test 07/17/2023

Guide Updated on Device Development Tools 07/17/2023

Ex-FDA Chief Counsel Joins Berkley Research 07/17/2023

AstraZeneca RSV Drug Beyfortus Approved 07/17/2023

FDA Warns About Using RoyalVibe Ultrasounds 07/17/2023

Fresenius Kabi Facility Hit With FDA-483 07/14/2023

MedRhythms Stroke Neurorehabilitation System Cleared 07/14/2023

EarliTec Autism Second Gen Device Cleared 07/14/2023

Bill Introduced on Biosimilar Substitutions 07/14/2023

Guide on Postmarketing Study Noncompliance 07/14/2023

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