The FDA intends to promote the “least burdensome” rules for companies big and small that are seeking to develop new therapies, “while ensuring patient safety.”
“Our policy will allow product manufacturers that time to engage with the FDA to determine if they need to submit a marketing authorization application and, if so, seek guidance on how to submit their application to the FDA for approval,” Gottlieb said.
The new rules are in keeping with provisions from the 21st Century Cures Act, passed by Congress in December. That legislation earmarked $6.3 billion in funding, mostly for the U.S. National Institutes of Health, towards groundbreaking medical research.
Over the past few years scientists and physicians have developed tissue-engineered skin for transplant; bladders grown from a patient’s own cells; and tissues grown to repair ailing hearts or failing knees.
Development of tissue engineering and regenerative medicine are being boosted with the rules.