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The U.S Food and Drug Administration (FDA) has awarded grants to five research institutes for the study and improvement of biomanufacturing, including 3D bioprinting.
Scott Gottlieb, MD, FDA Commissioner, said, “Advanced manufacturing technologies, such as continuous manufacturing, hold great promise for improvements in the reliability, flexibility, and cost-effectiveness of manufacturing for biological products.”
WE - AWARDED - IN - GRANTS - TO
“WE AWARDED IN GRANTS TO FIVE GLOBALLY-RECOGNIZED RESEARCH INSTITUTIONS TO STUDY WAYS IN WHICH CUTTING-EDGE MANUFACTURING TECHNOLOGIES CAN BE IMPLEMENTED TO ADVANCE THESE GOALS, AND ENABLE MORE INNOVATIVE, CONSISTENT, AND DEPENDABLE MANUFACTURING OF BIOLOGICAL PRODUCTS”
Each research institute will focus on a specific area in the field of biomedicine. The five institutes granted the award are:
Carnegie-Mellon - University - Assets - Manufacturing - Needs
Carnegie-Mellon University will focus its assets on “addressing key manufacturing needs for extracellular matrix scaffold 3D printing.”
The FDA invoked the 21st Century Cures Act (Cures Act) to award the five grants. The Cures Act (December 13, 2016) gives the federal agency the authority to develop projects that would accelerate innovations in medicine.
Projects - Regenerative - Medicine - Advanced - Therapy
Such projects include the Regenerative Medicine Advanced Therapy (RMAT), and the Breakthrough Devices program.
RMAT is an expedited option for eligible biological products. These products include regenerative medicine therapy drugs, those intended to treat life-threatening illnesses, and drugs which have “potential to address unmet medical needs” for life-threatening illnesses.
Breakthrough - Devices - Program - Review - Process
The Breakthrough Devices program speeds up the review process of certain medical devices. For a medical device to be considered under this program it is necessary to prove:
– The availability of the device is in the best interest of patients...
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