The FDA (Food and Drug Administration) is rolling out a new “regulatory framework” aimed at encouraging and speeding legitimate development of regenerative therapies.
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.
Brian Wang is a prolific business-oriented writer of emerging and disruptive technologies. He is known for insightful articles that combine business and technical analysis that catches the attention of the general public and is also useful for those in the industries. He is the sole author and writer of
nextbigfuture.com, the top online science blog. He is also involved in angel investing and raising funds for breakthrough technology startup companies.
He gave the recent keynote presentation at Monte Jade event with a talk entitled the Future for You. He gave an annual update on molecular nanotechnology at Singularity University on nanotechnology, gave a TEDX talk on energy, and advises USC ASTE 527 (advanced space projects program). He has been interviewed for radio, professional organizations. podcasts and corporate events. He was recently interviewed by the radio program Steel on Steel on satellites and high altitude balloons that will track all movement in many parts of the USA.
He fundraises for various high impact technology companies and has worked in computer technology, insurance, healthcare and with corporate finance.
He has substantial familiarity with a broad range of breakthrough technologies like age reversal and antiaging, quantum computers, artificial intelligence, ocean tech, agtech, nuclear fission, advanced nuclear fission, space propulsion, satellites, imaging, molecular nanotechnology, biotechnology, medicine, blockchain, crypto and many other areas.
