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Our newest blog is a review of the recent FDA Draft Guidance release on potential changes to Hepatitis B Testing for Blood Products
Update: Comment Period Ends – AATB Response to FDA Draft Guidance Document Sepsis
Our next blog covers AATB’s comments for the FDA with regard to their draft guidance on Sepsis
Update: Comment Period Ends – AATB Response to FDA Draft Guidance Document Mycobacterium Tuberculosis
Our newest blog highlights the AATB’s comments to the FDA’s draft guidance ““Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products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Our latest blog covers the recent draft guidance, “Unique Device Identifier (UDI) Requirements for Combination Products” that is currently in its comment period.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
The New Adventure of FDA and Elsa A.I.
Our newest Blog speaks to the implementation of the A.I. system, “Elsa” and the debate over artificial intelligence within the industry.
FDA’s Global Harmonization Efforts in Medical Device
Our next blog covers the Intersection between ISO 13485: 2016 and the FDA QSR, and how this impacts the future
ISO 13485:2016 – Why Is This Important For Medical Device Manufacturers?
A must read! This blog covers the International Organization for Standardization: who they are, and why you need to know if entering the International Medical Device Market
Influencing the FDA: What is the Comment Period?
Our newest blog post covers FDA Comment Periods and how it allows the public and shareholders to have a say in the newest guidances
AATB and the Tissue Banking Industry: Response to FDA’s Mtb and Sepsis Guidance Documents
Our latest blog covers how to better understand the role of the AATB in response to FDA’s recent guidance on Mtb and Sepsis
NIST Impacting Our Industry
In our latest blog, we explore how the National Institute of Standards and Technology ties to our industry more so than you may think.
Pipeline News for Malaria from the Blood Banking Industry and How it Could Impact the Tissue Banking Industry
Reviewing the FDA’s guidance “Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria” and how it affects the Tissue Banking Industry.
Navigating the CDC Website and Other Resources
Our next blog covers navigating the CDC website and other resources within our industry
Navigating the FDA Website and Other Resources
This blog is an in-depth look at navigating the FDA website
Risk Management for Your Supply Chain
Our latest blog highlights the challenges and risk mitigation tools needed to successfully navigate Supply Chain considerations
Hepatitis C Virus (HCV) and Our Industry: FDA’s Upcoming Guidance
Here is the latest FDA Guidance on Hepatitis C and its impact to our Industry
Hepatitis B Virus (HBV) and Our Industry: FDA’s Upcoming Guidance
Read here about the Food and Drug Administration’s (FDA) updates for Hepatitis B Virus (HBV)