Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
Learn more about the latest FDA Guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” now open to the public for comment.
I SOOOO WANT TO KNOW ISO/IEC 27001 for Information Security, Cybersecurity and Privacy Protection
Check out our latest blog on ISO 27001!
The Relationship with Our “X’s”: Good Clinical Practice – One of the “X’s” in GXP
Our latest blog covers Good Clinical Practices and the recent guidance: E6(R3) Good Clinical Practice, Guidance for Industry. Learn the global role of the International Council for Harmonisation (ICH) and where they fit into this topic!
Moving from Manual Systems – Automation in Progress for Tissue Bank Establishments
Is your organization seeking to modernize and implement ERP Systems? This blog covers the transition from manual systems with regard to Tissue Bank Establishments
Computer Software Assurance for Production and Quality System Software
Today’s blog covers key points on the approach an establishment should take with regard to validation and assurance of software used in medical device production and quality systems.
The Critical Role of Donor Eligibility Determination – Safeguarding Recipients
Today’s blog post covers Donor Eligibility Requirements, guided by FDA and AATB regulations, to safeguard recipients and transform lives
Navigating Medical Device Manufacturing – 510(k), PMA, De Novo, Oh My!
Learn all about Medical Device Manufacturing in today’s blog!
Introduction to the Basics of the Biologics License Application (BLA) Process
Today’s blog covers the phases and process of Biologics License Application (BLA).
Complete Response Letters – When Your Submission Application Isn’t Granted
The latest blog covers Complete Response Letters and the recent publication that FDA has released.
Training: The Critical Role in Tissue Banking
Our newest blog covers the importance of training in tissue banking, and how to refine your process!
Quality Agreements – The Robust Cornerstone of Tissue Safety and Compliance
Our newest blog covers Quality Agreements! What are they?, what are the benefits, and how to build an effective Quality Agreement
Machine Learning: The Era of Artificial Intelligence in Our Industry – 101
Today’s blog provides the basics of understanding Artificial Intelligence in the Life Sciences Industry
Quality Management System Audits: Navigating 21 CFR 1271 and AATB
This blog features navigating Internal Quality Audits!
Pipeline News for Hepatitis B Surface Antigen Testing in Blood Banking and Will This Impact HCT/Ps?
Our newest blog is a review of the recent FDA Draft Guidance release on potential changes to Hepatitis B Testing for Blood Products
Update: Comment Period Ends – AATB Response to FDA Draft Guidance Document Sepsis
Our next blog covers AATB’s comments for the FDA with regard to their draft guidance on Sepsis
Update: Comment Period Ends – AATB Response to FDA Draft Guidance Document Mycobacterium Tuberculosis
Our newest blog highlights the AATB’s comments to the FDA’s draft guidance ““Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”
Unique Device Identifier (UDI) Requirements for Combination Products
Our latest blog covers the recent draft guidance, “Unique Device Identifier (UDI) Requirements for Combination Products” that is currently in its comment period.
FDA’s Remote Regulatory Assessment (RRA) Guidance Update
Our latest blog covers the establishment of the Remote Regulatory Assessment (RRA) and the FDA’s final guidance, “Conducting Remote Regulatory Assessments”
FDA Inspections: Focus Points for Biologics, Medical Device, & Drug Manufacturers
Our newest blog covers FDA inspections, and what their top observations are relevant to Biologics, Medical Devices, and Drug Products