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Clinical Investigation Electronic Systems Guidance 03/15/2023

Bill to Streamline Generic Drug Approvals 03/15/2023

Former Drug Sales Rep Pleads Guilty 03/15/2023

FDA Reviewers Seem Positive on Paxlovid NDA 03/15/2023

Mixed Stakeholder Views on Orange Book Listings 03/15/2023

Profounda ‘Significant’ CGMP Violations 03/14/2023

House GOP Probes Covid ‘Political Interference’ at FDA 03/14/2023

More Comments on Patent Office/FDA Collaboration 03/14/2023

Characterizing MRD Data in Cancer Trials 03/14/2023

Petition Against BD’s Breast Reconstruction Device 03/14/2023

CGMP Violations at Formology Lab 03/14/2023

‘Objectionable Conditions’ at Avanti Study Site: FDA 03/14/2023

FDA Webview Reaches Out for Your Guidance 03/13/2023

FDA Clears PeekMed Orthopedic Surgery Planner 03/13/2023

Most Drug Shortages are Manufacturing Related: FDA 03/13/2023

FDA Clinical Hold on Mersana Tumor Drug 03/13/2023

Guide on Gastric pH-Dependent Drug Interactions 03/13/2023

FDA/CDC Correct Florida Official’s Vaccine ‘Misinformation’ 03/13/2023

Panel to Review Entasis Therapeutics NDA 03/10/2023

GAO Report Hits FDA on Advanced Manufacturing Tracking 03/10/2023

FDA Outlines Disposition of Covid-19 Guidances 03/10/2023

Pfizer NDA for Migraine Nasal Spray OK’d 03/10/2023

18 Senators Want End to Accelerated Approval Pricing Model 03/10/2023

Baxter Device Correction for Life2000 Ventilator 03/10/2023

FDA, EMA Parallel Scientific Advice is Effective: Study 03/09/2023

Lilly Drops Solanezumab on Negative Results 03/09/2023

How Can FDA Combat Medical Misinformation? 03/09/2023

FDA Seeks $372 Million (10%) Budget Boost for FY 2024 03/09/2023

Former Stimwave CEO Indicted 03/09/2023

FDA Updates EUA Listing for Medical Devices 03/09/2023

Mesoblast Remestemcel-L BLA Resubmitted 03/08/2023

Updated Safety Alert on Breast Implant Cancer 03/08/2023

FDA Accepts BioMarin Voxzogo New Indication sBLA 03/08/2023

Covis Willing to Voluntarily Withdraw Makena 03/08/2023

FDA’s Cancer Patient-Focused Glossary 03/08/2023

USP Launches Nitrosamines Analytical Hub 03/08/2023

FDA Bioresearch Inspection Findings Out 03/08/2023

Determine NMN is a Dietary Supplement: Petition 03/08/2023

Lithium Citrate Not Withdrawn Due to Safety/Efficacy 03/07/2023

FDA Extends Review Date for BioMarin’s Roctavian 03/07/2023

FDA Highlights ‘Proactive and Innovative’ Opioid Research 03/07/2023

Thomas Advanced Medical Illegally Selling HCT/Ps: FDA 03/07/2023

FDA Withdraws Fosun ANDA for Pemoline 03/07/2023

Abbott Alinity I Concussion Blood Test Cleared 03/07/2023

Update Accelerated Approval Labels with Required Info: Study 03/07/2023

More Hemodialysis Toxic Compound Analysis Needed: FDA 03/07/2023

FDA Grants De Novo Device for Tinnitus 03/07/2023

Aclaris Skin Condition Study Misses Endpoint 03/07/2023

Some Guidance Changes Helpful, More Needed: AAM 03/07/2023

Dupixent sBLA for Chronic Spontaneous Urticaria 03/07/2023

Questions on Oncologic Investigational Agent Guidance 03/07/2023

Incyte Abandons Phase 3 Myelofibrosis Trial 03/06/2023

FreeStyle Sensors for Automated Insulin Delivery 03/06/2023

FDA Increasing Oversight on Diethylene Glycol Contamination 03/06/2023

Novartis Petitions FDA on Dosing Titration Info Requirement 03/06/2023

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

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

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

Drug Continuous Manufacturing Guidance 03/03/2023

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

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

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

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

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