Blog - Page 3 of 10 - Compliance Insight

April 12, 2023by t_king

Understanding CAR T-cell Therapy

March 31, 2023by t_king

The Importance of Pre-Approval Inspection (PAI)

March 24, 2023by t_king

FDA Announces OTC Monograph User Fee for 2023

March 21, 2023by t_king

The Benefits of Cell and Gene Therapy

March 13, 2023by t_king

FDA Clarifies Status of COVID-19 Guidance Documents Ahead of PHE Expiration

March 9, 2023by t_king

The Ten Core Principles of GMP Compliance

March 7, 2023by t_king

The Latest Update on the Umbrella EUA for Surgical Masks

March 2, 2023by t_king

Gene therapy is revolutionizing the way we treat genetic diseases

March 1, 2023by t_king

Clarify Regulatory Authority with FDORA Improvements

February 22, 2023by t_king

Monkeypox Emergency Authorization (EUA)

Document with title Audit

February 21, 2023by t_king

Are you prepared for when the FDA arrives…

Warning Letter

February 16, 2023by t_king

How to prepare for FDA Inspections

UDI_USA

February 7, 2023by t_king

Understanding UDI Requirements for Medical Devices

January 31, 2023by t_king

CBER Updates: What you need to know

January 16, 2023by t_king

What is an Unique Device Identifier (UDI)?

December 23, 2022by t_king

Happy holidays one and all!!

August 2, 2022by t_king

Goodness Gracious, Great Balls of Fire!

July 5, 2022by t_king

FDA Urges Drug Manufacturers to Implement Stronger Risk Management Plans

June 28, 2022by t_king

What is an UDI and why does it matter?

June 16, 2022by t_king

FDA authorizations for EUAs

Medical-Devices-scaled

June 7, 2022by t_king

The FDA Is Adopting ISO 13485: What This Means for Medical Devices