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Califf Sees Misinformation as Cause of Preventable Deaths 02/17/2023

GE Recalls ‘Unstable’ Nuclear Medicine Devices 02/16/2023

Drug R&D Can’t Justify High Prices: Study 02/16/2023

Further FDA Opioid Crisis Strategies: Califf 02/16/2023

30 New Product-Specific Guidances Out 02/16/2023

Pfizer Says Talzenna Prostate Cancer Study ‘Positive’ 02/16/2023

FDA Approves BioVex BLA Supplement 02/16/2023

GAO Identifies FDA Gaps in IRB Oversight 02/16/2023

FDA Pushed Into Accelerated Approval Pricing Model 02/15/2023

MCM Annual Report Achievements 02/15/2023

FDA Keeps Concert Drug’s Breakthrough Status 02/15/2023

Court Action on 3 Claims Explained 02/15/2023

Pediatric Drug Extrapolation in U.S. Analyzed 02/15/2023

Bryan Concerns About Gene Therapy Accelerated OKs 02/15/2023

FDA Facing Backlog of ODE Determinations: Attorneys 02/15/2023

AdvaMed Comments on Inspection Delay Guidance 02/15/2023

Panel Unanimously Backs Non-Rx Narcan 02/15/2023

CGMP Violations in Delta Kozmetik Sanayi Inspection 02/14/2023

Multiple Violations in Unapproved Wintech Medipro Masks 02/14/2023

11 Republicans See FDA/Industry ‘Revolving Door’ 02/14/2023

FDA Alternative Review Tools ‘Critical’ in Decisions: Study 02/14/2023

Marks Wants ‘Project Orbis’ for Cell/Gene Therapies 02/14/2023

FDA Learning to Combat Social Media Disinformation 02/14/2023

Benefit-Risk is Top CBER Panel Issue: FDA 02/13/2023

Ocuphire Pharma NDA for Eye Dilation Reversal 02/13/2023

Repackaging Propofol During Covid Guide Withdrawn 02/13/2023

10% of FDA-approved Drugs Had Null Findings: JAMA 02/13/2023

Inspection Troubles Hit Biocon’s Avastin Biosimilar 02/13/2023

Ethicon $10 Million Settlement Over Surgical Mesh 02/13/2023

Neonatal Neurodevelopmental Safety Study Guide 02/10/2023

ODAC Panel Backs Proposed Jemperli Studies 02/10/2023

New AI Tools Will Require FDA Flexibility: Califf 02/10/2023

HHS Roadmap Outlines FDA Flexibilities Post-Covid 02/10/2023

Phathom Gets 2 Complete Response Letters Over Impurity 02/10/2023

FDA to Explain Post-Health Emergency Effects 02/09/2023

Eiger Won’t Seek EUA for Interferon Covid Treatment: Bloomberg 02/09/2023

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

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