FDA issues guidance about regenerative medicine

March 4, 2019

Two regenerative medicine guidance documents drafted last year have now been published by the U.S. Food and Drug Administration. The documents clarify new considerations on the development and review of regenerative medicine therapies.

The first guidance deals with the evaluation of devices used with regenerative medicine advanced therapies. The second guidance covers expedited programs for regenerative medicine therapies for serious conditions.

The FDA guidances provide a streamlined process for moving novel cellular therapies and devices from research and development to commercial distribution, while ensuring safety and efficacy.

These expedited processes also help reduce the cost and challenges preventing new and promising regenerative medicine products from being available to patients.

“With our experience in human cells and tissues, and 45 year legacy of regulated product manufacturing under good manufacturing and quality practices, BioBridge Global can help drug and device development companies deliver their products to clinical settings in the most efficient, highest quality and safest manner,” said Adrienne Mendoza, VP of Global Quality & Compliance at BioBridge Global.

“We can help their accelerated product commercialization process and reinforce our mission to save and enhance lives through the healing power of cells and tissue.”

More from our blog:

Making a supply of platelets using stem cells from fat cells

RegenMed SA shows potential of region’s regenerative medicine industry

FDA modifying medical device process