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FDA Updates Philips MDRs; 82 Deaths in 2 Months 02/09/2023

FDA Denies DuraSeal Spinal Sealant Petition 02/09/2023

DoJ Wants Conspiracy Charge Against KVK-Tech 02/09/2023

Senate Judiciary Committee Clears 5 Drug Bills 02/09/2023

CBER in a ‘Transition Year’: Marks 02/08/2023

EUA for BD Combination Covid-Flu-RSV Test 02/08/2023

FDA Unsure of ‘Unprecedented’ Jemperli Trial Plans 02/08/2023

Industry VMSR Improvement Suggestions 02/08/2023

CDER Researches Convolutional Neural Networks 02/08/2023

Califf Sails Through 1st Covid Oversight Hearing 02/08/2023

QS, Other Violations at Getsch+Hiller Medizintechnik 02/07/2023

FDA Criminal Probe Nets Device Maker Indictment 02/07/2023

8 Inspection Takeaways from New FDA Law 02/07/2023

OCE Slowed New Projects in 2022 02/07/2023

Comments on FDA/Patent Office Collaboration 02/07/2023

Kessler Praises Marks on Covid Response Leadership 02/07/2023

Lower Added Benefit Associated with Higher DTC Spend 02/07/2023

Court Throws Out PhRMA Lawsuit on Drug Importation 02/07/2023

FDA Offers Advisory Committee Hearing on Intarcia Dispute 02/07/2023

FDA Urges Reporting of Home Covid Test Results 02/06/2023

Rapid-Acting Depression Drug Gets Priority Review 02/06/2023

MD Sentenced in Avanir Kickbacks 02/06/2023

Abbott Expanded Indication for Ablation Catheter 02/06/2023

Tezspire Approved as Pre-filled Pen for Asthma 02/06/2023

Sandoz Prolia/Xgeva Biosimilar BLA Submitted 02/06/2023

Man Fakes Cancer to Skip FDA Misbranding Trial 02/03/2023

Device Co. Pays $500K over False Claims: DoJ 02/03/2023

Trodelvy OK’d for Pre-treated Metastatic Breast Cancer 02/03/2023

Senators Urge Danco Labs to Expand Mifepristone’s Use 02/03/2023

Attorneys Dismiss ‘Hype’ on FDORA Animal Testing Provision 02/03/2023

FDA Clinical Hold on 4D Molecular Fabry Drug 02/03/2023

Device Conformity Assessment Pilot Becoming Permanent 02/03/2023

GSK’s Oral Anemia Drug Approved for Dialysis 02/02/2023

Greenleaf Health Hires 2 Former FDA Officials 02/02/2023

FDA Warning, Import Alert on Contaminated Eyedrops 02/02/2023

Philips BiPAP, CPAP Mask Recall is Class 1: FDA 02/02/2023

FDA Strategy on Opioid Reversal Products Nears Fruition 02/02/2023

PMR/PMC Annual Statistical Report 02/02/2023

Consider Mfg. Issues in Preparedness Planning: GAO 02/02/2023

GoodRx Paying $1.5 Million for Consumer Data Breach 02/02/2023

Ways to Mitigate Park Doctrine Risks: Attorney 02/02/2023

Expanded Indication for Abbott Heart Catheter 02/02/2023

Fraudulent Contract Research Org. Leads to Debarment 02/02/2023

Glucosamine Case Can Inform Drug, Device Cases: Attorney 02/02/2023

M13A Bioequivalence Consensus Guideline 02/01/2023

Positive Covid Test Requirement Lifted on 2 Therapeutics 02/01/2023

No Justification for Lexicon Hearing: CDER 02/01/2023

CDER Planning 98 New, Revised Guidances for 2023 02/01/2023

Lyme Disease Drug Development Guidance 02/01/2023

IBSA Recalls Some Tirosint-Sol Lots 02/01/2023

Clarius Mobile’s Musculoskeletal AI Measurer 02/01/2023

Xenex Files De Novo for Disinfection Device 02/01/2023

RightEye Promoting Off-Label Use: FDA 01/31/2023

Multiple Violations at Adept Life Science 01/31/2023

GDUFA 2022 Science and Research Report 01/31/2023

Improve Biosimilar Development and Approval Efficiency 01/31/2023

Externally Controlled Trial Guidance 01/31/2023

FDA 'Defying' Appeals Court is Troubling: Attorneys 01/31/2023

CBER 2023 Guidance Agenda 01/31/2023

Biden Administration Ending Public Health Emergency 5/11 01/31/2023

CBER Tissues/Advanced Therapies Director Bryan Retiring 01/31/2023

Califf Proposes ‘Transformation’ of Foods Program, ORA 01/31/2023

Class 1 Recall of Smiths CADD Infusion Sets 01/31/2023

Guide on Lasers for Surveying, Leveling and Aligning 01/30/2023

Class 1 Recall of Medtronic ‘Leaky’ Catheters 01/30/2023

Guide on Acromegaly Drug Development 01/30/2023

Consent Decree Against LGM Pharma 01/30/2023

CDER/CBER Restarting In-Person Industry Meetings 01/30/2023

Oracle Technology Guru Named FDA Digital Health Director 01/30/2023

Lawsuit Against FDA and Livestock/Poultry Antibiotic Use 01/27/2023

FDA Funding Opportunity for Pediatric Device Consortia 01/27/2023

New Data Support Carvykti sNDA in Multiple Myeloma 01/27/2023

Vanda Petitions FDA Over Teva ‘Non-Braille’Labeling 01/27/2023

FDA Denies Petition on Jakafi Safety Labeling 01/27/2023

Eschoo Reelected as Ranking Dem on Health Subcommittee 01/27/2023

LivaNova Again Recalls LifeSPARC Controller Over Software 01/27/2023

Rep. Guthrie to Chair FDA Oversight Committee 01/26/2023

FDORA Requires Trial Diversity Action Plans: Attorneys 01/26/2023

New CBD Regulatory Framework Needed: Woodcock 01/26/2023

Biological Therapies Need Clinical Trials: Califf, Marks 01/26/2023

Include all Media in Drug Promotion Regs: Professors 01/26/2023

CDRH OK’d 19 Breakthrough Devices in 2022 01/26/2023

Dental Practices Defrauded FDA: Justice Dept. 01/26/2023

Torrent Inspection Classified as Official Action Indicated 01/26/2023

No Evidence of Contaminated Cough Syrup in U.S.: FDA 01/26/2023

Panel Backs Plan to Harmonize Covid Vaccine Composition 01/26/2023

Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions 01/25/2023

Final Guide on Compounding Ibuprofen Suspensions 01/25/2023

Cardiosave Intra-Aortic Balloon Pumps Recalled 01/25/2023

Improving Myelodysplastic Syndromes Trials 01/25/2023

FDA Lifts Hold on Inhibikase Parkinson’s Trial 01/25/2023

BsUFA Regulatory Research Roadmap 01/25/2023

FDA/Aetion Oncology RWD Research 01/25/2023

GenBioPro Sues to Overturn WV Abortion Pill Law 01/25/2023

Merck Ending Keytruda Phase 3 Prostate Cancer Trial 01/25/2023

Panel Votes to Approve Cidara’s Rezafungin 01/25/2023

‘7 Deadly Sins’ at FDA Presentations: Mikkael Sekeres 01/24/2023

Biogen’s Lou Gehrig’s NDA Heads to Panel Review 01/24/2023

AdvaMed Device Sterilization Reg Proposals for EPA 01/24/2023

Lobbying Killed VALID Act: ProPublica 01/24/2023

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