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‘Priority’ for Alzheimer’s sBLA Seeking Traditional Approval 03/06/2023

DoJ Preferring Deferred Prosecution Agreements: Attorneys 03/06/2023

Veru EUA Request for Covid Drug Denied 03/03/2023

Lilly Gets Expanded Indication for Verzenio 03/03/2023

FloSpine 3D-Printed Interbody Cage Cleared 03/03/2023

Exelixis Renal Cell Carcinoma Study Misses Endpoint 03/03/2023

Drug Continuous Manufacturing Guidance 03/03/2023

CDER 2022 Drug Safety Priorities Report Out 03/02/2023

FDA, FTC Advancing Biologic Competition 03/02/2023

Panel to Review Lynparza sNDA for Prostate Cancer 03/02/2023

Drug, Device Recalls Shoot Up in 2022: Report 03/02/2023

8 Observations in Cipla FDA-483 03/02/2023

Many Deficiencies in Musk Neuralink Brain Chip: FDA 03/02/2023

FDA, Expert Debate Bivalent Covid Vaccine Deployment 03/02/2023

Q13 Drug Continuous Manufacturing Guidance 03/01/2023

FDA Mulls Artificial Intelligence Use in Drug Manufacturing 03/01/2023

Multiple Violations Seen in Skyless Inspection 03/01/2023

Monoclonal Antibody Potency Assay Guidance 03/01/2023

FDA Highlights Rare Disease Day 2023 with ARC 03/01/2023

eSTAR Template ‘Early Learnings’: Regulation Expert 03/01/2023

Panel Backs GSK Vaccine for RSV in Older Adults 03/01/2023

Cytokinetics Gets NDA Complete Response Letter 03/01/2023

4 New CBER Standard Policies and Procedures 02/28/2023

FDA Restricting Unlawful Importing of Xylazine 02/28/2023

FDA, FTC Biosimilar Workshop Summary Out 02/28/2023

Califf Expands on ORA Restructuring 02/28/2023

Group Petitions for More Trial Reporting Enforcement 02/28/2023

FDA Seeks Comments on AI Areas in Drug Manufacturing 02/28/2023

CDER Neuroscience Director Dunn Leaving Agency 02/27/2023

FDA Warning on Abbott Trifecta Heart Valves 02/27/2023

FDA Raises Guillain-Barre Monitoring on RSV Vaccine 02/27/2023

Verrica Pharma NDA Resubmitted for Skin Infection 02/27/2023

FDA Debars Ex-Indivior CEO for 5 Years 02/27/2023

CDER Taps Deputy Furman as Compliance Director 02/24/2023

FDA Grants EUA for First OTC Flu/Covid Test 02/24/2023

Chantix Not Withdrawn Due to Safety/Efficacy 02/24/2023

Lawsuit Seeks REMS Removal on Mifepristone 02/24/2023

Guide on ‘Wet Age’ Macular Degeneration Drugs 02/24/2023

Califf Pushes Improved Evidence Generation System 02/24/2023

PhRMA Proposes Changes to M11 Guidance 02/23/2023

CMS Continues Block on Alzheimer’s Drug Coverage 02/23/2023

FDA Urged to Pull Failed Cancer Drugs Faster 02/23/2023

Ivermectin Not Effective in Treating Covid: Study 02/23/2023

FDA Evaluating Neonatal Incubator Airborne Chemicals 02/23/2023

USPTO Should Check Keytruda Patent Requests: Lawmakers 02/23/2023

Human Factor Guidance is FDA ‘Mission Creep’: Attorney 02/23/2023

Amneal Pharmaceuticals FDA-483 Released 02/22/2023

Lessons Learned from Covid Vaccine Development 02/22/2023

Asacol Not Withdrawn Due to Safety/Efficacy 02/22/2023

Topamax Not Withdrawn Due to Safety/Efficacy 02/22/2023

AAM Praises Controlled Correspondence Guidance 02/22/2023

FDA Publishes 3 X-Ray Guidances 02/22/2023

FDA Accepts Elranatamab BLA for Priority Review 02/22/2023

Artificial Tears Warning Expanded 02/22/2023

RapidAI RV/LV Analyzer for Pulmonary Embolism Cleared 02/22/2023

High Court Refuses to Hear J&J Mesh Case 02/22/2023

Akebia Vadadustat Dispute Resolution Delayed 02/21/2023

FDA Extends Astellas Fezolinetant PDUFA Action Date 02/21/2023

FDA Limited in Fighting Misinformation: Califf 02/21/2023

510(k) Guidances for 2 Ultrasound-type Devices Published 02/21/2023

Intarcia Agrees to Advisory Committee to Resolve Review Dispute 02/21/2023

Regulatory Agenda Eyes DTC Ads and Med Guides 02/21/2023

Pfizer Drops Many U.S. Lyme Trial Participants 02/17/2023

Priority Review for Merck Prevymis sNDA 02/17/2023

FDA to Review Iveric NDA for Avacincaptad Pegol 02/17/2023

Comments Sought on WHO Drug Scheduling 02/17/2023

Eisai Expects FDA to Approve Alzheimer’s Drug Soon 02/17/2023

FDA OKs Chiesi’s Lamzede for Alpha-Mannosidosis 02/17/2023

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

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

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

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

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