Compliance Insight, Inc.

04/12/2023

Personalized medicine at its best - CAR T-cell therapy uses your own immune system to target and kill cancer cells!

CAR T-cell therapy has been approved by the FDA for the treatment of certain types of blood cancers, such as leukemia and lymphoma

03/31/2023

Pre-approval inspection of manufacturing facilities is essential to ensure that the drug produced complies with Good Manufacturing Practices.

To prepare for a Pre-Approval Inspection PAI, companies must undergo a lengthy process of ensuring compliance with cGMP requirements

03/24/2023

Don't miss this important update - stay informed on FDA's new over-the-counter monograph drug user fee rates for FY2023! See details here:

The FDA’s OTC Monograph Drug User Fee Program (OMUFA) website is a great resource for those who need more information

03/21/2023

The 21st century has seen some remarkable breakthroughs in medical science, with groundbreaking advancements in cell and gene therapy leading the way! https://tinyurl.com/58avut9k

Find out how cell and gene therapy can be used to treat a wide range of conditions, from cancer to genetic disorders.

03/14/2023

Happy everyone! Today we celebrate the mathematical constant π (pi) and all the incredible ways it's used in our world. Whether you're a math lover or just appreciate a good slice of pie, take a moment to appreciate the beauty of this never-ending number! 🥧🤓🎉

03/13/2023

FDA provides an update on COVID-19 guidance documents! The agency clarifies which guidances will no longer be in effect and which ones will be revised to remain in effect after the public health emergency declaration ends.

The U.S. Food and Drug Administration (FDA) has published a Federal Register notice detailing the status of guidance documents

03/09/2023

The Ten Core Principals of GMP Compliance are the foundation of a successful quality management system. They provide a guide to manufacturing products safely and consistently, meeting customer needs and regulatory requirements.

The Ten Core Principals of GMP Compliance are the foundation of a successful quality management system. They provide a guide to manufacturing

03/08/2023

It's time to get your networking game on!

Come join us at the Festival of Biologics in San Diego from March 20-22. We'll be there, so you know we'll be ready to make connections with the people who can help you get where you want to go.

We're looking forward to seeing you there!

03/08/2023

Happy International Women's Day! Today, let's celebrate all of the incredible and inspiring women who have made a difference in our lives. Here's to taking charge, pushing boundaries, and smashing stereotypes!

03/07/2023

Don't miss out on this important information: the FDA has revised and reissued the EUA for disposable surgical masks.

Stay informed on the latest changes to the FDA's umbrella Emergency Use Authorization (EUA) for single-use surgical masks

03/02/2023

Healthy DNA meets innovation: with gene therapy, we can insert new genes and suppress others for improved health outcomes!

Gene therapy is founded on the understanding that genetic mutations can be responsible for causing various diseases.

03/01/2023

The new FDORA law defines facilities subject to BIMO inspections, their purposes, records & information subject to inspection

The introduction of Section 3612 of FDORA is a fundamental step towards safeguarding high standards of ethical research practices for BIMO