Katie Laney 6/23/25 Katie Laney 6/23/25

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

Katie Laney 6/16/25 Katie Laney 6/16/25

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.

Katie Laney 6/11/25 Katie Laney 6/11/25

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

Katie Laney 6/2/25 Katie Laney 6/2/25

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

Katie Laney 5/27/25 Katie Laney 5/27/25

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

Katie Laney 5/19/25 Katie Laney 5/19/25

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

Katie Laney 5/12/25 Katie Laney 5/12/25

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.

Katie Laney 5/8/25 Katie Laney 5/8/25

UPDATE: FDA Rescinds Previous Implementation Timelines for Mycobacterium Tuberculosis (Mtb) and Sepsis Guidance Documents, Welcomes Public Comments for Their Revised Draft Documents

Katie Laney 5/5/25 Katie Laney 5/5/25

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.

Katie Laney 4/29/25 Katie Laney 4/29/25

Navigating the CDC Website and Other Resources

Our next blog covers navigating the CDC website and other resources within our industry

Katie Laney 4/21/25 Katie Laney 4/21/25

Navigating the FDA Website and Other Resources

This blog is an in-depth look at navigating the FDA website

Katie Laney 4/14/25 Katie Laney 4/14/25

Risk Management for Your Supply Chain

Our latest blog highlights the challenges and risk mitigation tools needed to successfully navigate Supply Chain considerations

Katie Laney 4/8/25 Katie Laney 4/8/25

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

Katie Laney 3/31/25 Katie Laney 3/31/25

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)

Katie Laney 3/24/25 Katie Laney 3/24/25

Human Immunodeficiency Virus (HIV) and Our Industry: FDA’s Upcoming Guidance

Here is the latest highlight on Human Immunodeficiency Virus (HIV) and its impact to the Human Tissue industry

Katie Laney 3/10/25 Katie Laney 3/10/25

Extra Extra Read All About Our Sepsis Review!

Here is our latest blog the FDA Guidance document: “Recommendations to Reduce the Risk of Transmission of Disease Agents with Sepsis by Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps)

Delayed implementation of 5/4/25

Katie Laney 3/5/25 Katie Laney 3/5/25

The Buzz on Mycobacterium Tuberculosis (Mtb)

Here is our newest blog on the FDA guidance document:

“Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)”.