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Remote Interactive Evaluation Guidance 10/25/2023

Medinol Gets OK on Latest Drug-Eluting Stent 10/25/2023

FDA Decision on Florida Drug Imports Delayed: Report 10/25/2023

Akebia Refiles Kidney Disease NDA 10/25/2023

‘Positive Results’ from BioXcel Data Audit 10/25/2023

Califf Positive on Visit to India 10/25/2023

Dermatologic Corticosteroid BE Guidance 10/25/2023

FDA Approves New Tibsovo Indication 10/24/2023

UCB Farchim FDA-483 Released 10/24/2023

FDA Changes Off-Label Approach: Attorney 10/24/2023

ResMed Recalls Astral 100, 150 Ventilators 10/24/2023

FDA Accepts sBLA for Self-Administered FluMist 10/24/2023

Predetermined Change Control Plan Principles 10/24/2023

Embryll Marketing Unapproved Animal Drug: FDA 10/24/2023

FDA Clears NKGen IND for Alzheimer’s Cell Therapy 10/24/2023

Genentech’s Rozlytrek Gets Expanded Use 10/24/2023

Guide on Scientific Info on Unapproved Uses 10/23/2023

FDA Approves Zymfentra as Maintenance Therapy 10/23/2023

Panacea Biotec Gets 9-item FDA-483 10/23/2023

Complete Response on Dupixent sBLA 10/23/2023

Medtronic Warning on McGrath Video Laryngoscopes 10/23/2023

Keytruda ‘Positive’ Data in Cervical Cancer 10/20/2023

Pfizer Pentavalent Meningococcal Vaccine Approved 10/20/2023

Philips Respironics Recalls V60 Ventilators 10/20/2023

Arrest Made in Misbranded Device Case 10/20/2023

BioMarin Expanded Indication for Voxzogo 10/20/2023

FDA Updates AI/ML-Enabled Medical Device List 10/19/2023

Untitled Letter for India’s Nectar Lifesciences 10/19/2023

OCE Scientific Collaborative Research Areas 10/19/2023

Final Guide on Remote Monitoring Devices 10/19/2023

Hygienic Labs Didn’t Respond to FDA Data Requests 10/19/2023

BMS Seeking Approval of Subcutaneous Opdivo 10/19/2023

Confusion Exists in RWD/RWE Definitions: Analysis 10/19/2023

Regenerative Medicine Consensus Standards Guide 10/19/2023

Guide on Drug, Biologic Benefit/Risk Assessment 10/18/2023

SeaStar Breakthrough Status for Cytopheretic Device 10/18/2023

Courts Could Cut FDA Labeling Enforcement: Avorn 10/18/2023

FCA Cases Look at Cybersecurity: Attorneys 10/18/2023

BrainStorm Pulls NurOwn BLA 10/18/2023

Non-Invasive Monitoring Enforcement Guide 10/18/2023

FDA Clears Intellia IND for Phase 3 Trial 10/18/2023

Praxis 510(k) for Biopsy Device Cleared 10/17/2023

Keytruda OK’d Before/After Lung Cancer Surgery 10/17/2023

‘Is Chevron Deference Dead?’: Ex-FDAer Pitts 10/17/2023

Guilty Plea in SphenoCath Case 10/17/2023

FDA Wants Comments on Innovative Clinical Trials 10/17/2023

Verrica Asks FDA to End Ycanth Compounding 10/17/2023

6 Observations in Samsung Biologics FDA-483 10/17/2023

FDA Denies UCB Generic Fintepla Petition 10/17/2023

Providence Medical Tech Cavux Facet Device Cleared 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

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

States Pushing for Canadian Drug Imports: Report 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

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

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

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

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