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Consider Oncology Single-Arm Trial Issues: CDER 01/04/2023

Medical Device Consensus Standards Database Updated 01/04/2023

FDA Changes Mifepristone REMS 01/04/2023

FDA Reforms Included in Year-end Omnibus Bill 01/04/2023

Accord Healthcare Recalls 2 Daptomycin Products 01/04/2023

FDA Approves Acer’s Olpruva for Urea Cycle Disorders 01/04/2023

FTC Updates Health Products Compliance Guide 01/04/2023

CGMP Deviations Found at MD Pharmaceutical Supply 01/04/2023

RoyalVibe Health Refused Inspection: FDA 01/04/2023

Inspection Issues at Sagent’s Plattsburgh Facility 01/04/2023

FDA Lifts Partial Hold on Bluebird Bio Lovo-Cel Study 01/04/2023

Advanced Bionics Paying $12 Million Over False Claims 01/03/2023

Drug Risks and Benefits in CSL Communications 01/03/2023

‘Objectionable Conditions’ at Clinical Investigation Site 01/03/2023

M11 Clinical Electronic Structured Protocol 01/03/2023

FDA Pushing Naloxone OTC Switch: Attorney 01/03/2023

Hypertension Labeling for Cardio Claims Guidance 01/03/2023

Spending Bill Reverses Some FDA Court Losses: Attorneys 01/03/2023

FDA Discusses 2 New Trilogy Ventilator Issues 01/03/2023

FDA Needs More Global Help Against Crime: Hermsen 01/03/2023

Reactions to Aduhelm Report Blast FDA Closeness to Industry 01/03/2023

CGMP Deviations at Brazil’s Nortec Quimica 01/03/2023

FDA States Plan B One-Step Does Not Cause an Abortion 01/03/2023

Court Enters Consent Decree Against Oklahoma Compounder 01/03/2023

FDA Gets $226 Million Spending Boost in Budget Bill 01/03/2023

FDA Grants Ardelyx’ Xphozah Appeal 01/03/2023

Providence Medical Tech Cavux Facet Device Cleared 12/16/2022

NEWSROOM CLOSED FOR THE HOLIDAYS 12/16/2022

FDA OK’s Ferring’s Bladder Cancer Gene Therapy 12/16/2022

Panel to Examine Ongoing Covid Vaccine Modifications 12/16/2022

Contractor Conflict-of Interest Bill Passes Congress 12/16/2022

Aurigene Ditches Psoriasis Drug Candidate 12/16/2022

Draft Guide on Pulmonary Tuberculosis Drugs 12/15/2022

Draft Inspection Refusal Guidance 12/15/2022

FDA Stem Cell Therapy Regulation at Risk: Attorneys 12/15/2022

FDA Updates CRL Guidance Performance Goals 12/15/2022

Comments on Immune-Mediated Adverse Reaction Guidance 12/15/2022

Independent FDA Needed to Stop Political Meddling: GAO 12/15/2022

States Pushing for Canadian Drug Imports: Report 12/14/2022

Harmonize Innovative Manufacturing Regulation: PhRMA 12/14/2022

AdvaMed Supports Breakthrough Device Guidance Updates 12/14/2022

VALID Could Hurt Home Sample Testing: Attorneys 12/14/2022

Former NECC Ops Director Sentenced to 5 Months in Jail 12/14/2022

FDA Panel Thumbs Down on Heart Failure Drug 12/14/2022

FDA Accepts NDA for Eye Dilating Combo Product 12/13/2022

$2.25 mil. RWD Funding Opportunity 12/13/2022

CGMP Deviations Seen in Centrient Inspection 12/13/2022

Clinicians Need Refresher on Clinical Trial Statistics: Survey 12/13/2022

What’s Behind the New LASIK Guidance? 12/13/2022

Assign TE Codes for All Approved Drugs: Study 12/13/2022

Change Antibiotic Development Incentives: Study 12/13/2022

Moderna/Merck Cancer Vaccine Meets Endpoint 12/13/2022

Doc Group Wants FDA Probe of Musk’s Neuralink 12/13/2022

Smiths Device Correction on CADD Infusion System 12/12/2022

CVM Sees 1% Decrease in Food Animal Antimicrobial Use 12/12/2022

Academics Urge FDA to Simplify Breast Density Notifications 12/12/2022

DoJ Indictment on Unapproved Drugs 12/12/2022

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program 12/12/2022

FDA Hits 2 QuVA Pharma Facilities with 483s 12/12/2022

Green Pharmaceuticals’ SnoreStop ‘Adulterated’: FDA 12/11/2022

Empowered Diagnostics Unapproved Covid Tests 12/11/2022

FDA Will Review Pfizer Etrasimod NDA 12/11/2022

Address Prescription Adderall Shortage: Spanberger 12/11/2022

Academics Urge Tougher FDA Stance on Accelerated NDAs 12/09/2022

Device Voluntary Malfunction Summary Reporting Guide 12/09/2022

Remel Recalls Thermo Scientific Sensititre Plates 12/09/2022

Janssen Files BLA for Myeloma Therapy 12/09/2022

2 Roche Alzheimer’s Tests Cleared by FDA 12/09/2022

10 Observations in Aurobindo Unit FDA-483 12/08/2022

Non-Device Software Function Report 12/08/2022

Draft VMSR Guidance for Manufacturers 12/08/2022

16 Observations on Lupin Unit FDA-483 12/08/2022

FDA Proposes More Comprehensive IND Reports 12/08/2022

Draft Device Human Factors Guidance 12/08/2022

Comments on Pediatric Clinical Pharmacology Draft 12/08/2022

FDA Manuscript in the Works on Trial Diversity Strategy 12/08/2022

FDA Denies Homeopathy Petition 12/07/2022

Significant HCT/P Deviations at Cryos International 12/07/2022

FDA Denies Petition on Scrubs as Medical Devices 12/07/2022

PhRMA Issues with FDA Medical Queries 12/07/2022

Device Shortages Need More Transparency: FDA 12/07/2022

Coalition for Health AI Meeting Summary 12/07/2022

FDA Defends Training/Support of Team Biologics 12/07/2022

FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug 12/07/2022

FDA Accelerated Approvals Down This Year: AP 12/07/2022

Pass VALID Act Now: Former Commissioners 12/06/2022

Guide on PK-Based Criteria for PD1/PD-L1 Alt Dosing 12/06/2022

Contract Lab Valisure Relinquishes its Testing Prowess 12/06/2022

FDA Updates Endologix Endovascular Graft Safety 12/06/2022

AG Hair Limited CGMP Issues 12/06/2022

CGMP Violations at Glenmark Pharmaceuticals 12/06/2022

CGMP Violations in Kari Gran Inspection 12/06/2022

FDA Maintains ‘High Bar’ for P13K Inhibitors 12/06/2022

FDA Developed New Covid Drug Surveillance: Study 12/06/2022

Team Biologics Needs More Staff, Training: Former FDAers 12/06/2022

Firms Seek EUA for Omicron Vaccine in Young Children 12/05/2022

Novartis Seeking Expanded Pluvicto Use 12/05/2022

Guide on ‘Selective’ Drug Safety Data Collection 12/05/2022

Clinical Hold Issues Outlined for Cholesterol Gene Therapy 12/05/2022

FDA Confirms Survival Rate With Abiomed’s Heart Device 12/05/2022

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