Newsletter - April 8, 2016
HCT/Ps Get Support from Congress but Benefits are Limited
Last month in a rare bipartisan move, a new bill was introduced in the Congress to provide conditional approval to regenerative medicine products intended primarily to affect how FDA regulates the Human Cell, Tissue or cellular or tissue-based Products (HCT/Ps). The proposed bill, called the “Reliable and Effective Growth for Regenerative Health Options that Improve Wellness”, or the “REGROW Act” will create a pathway to market approval for HCT/Ps. Read More..
US Government to Help Create Manufacturing Processes for Cell-Based Medicine
Regenerative medicine was identified as one of the top priorities for the US government in a report from the Subcommittee for Advanced Manufacturing of the National Science and Technology Council that advises the US President. The report acknowledged that cell-based medicine holds great potential to address critical medical issues related to cells, tissues, and organs particularly in the treatment of severe injuries, redirect immune functions, and organ transplants. Read More..
HCT/Ps Get Support from Congress but Benefits are Limited
Last month in a rare bipartisan move, a new bill was introduced in the Congress to provide conditional approval to regenerative medicine products intended primarily to affect how FDA regulates the Human Cell, Tissue or cellular or tissue-based Products (HCT/Ps). The proposed bill, called the “Reliable and Effective Growth for Regenerative Health Options that Improve Wellness”, or the “REGROW Act” will create a pathway to market approval for HCT/Ps. Read More..
US Government to Help Create Manufacturing Processes for Cell-Based Medicine
Regenerative medicine was identified as one of the top priorities for the US government in a report from the Subcommittee for Advanced Manufacturing of the National Science and Technology Council that advises the US President. The report acknowledged that cell-based medicine holds great potential to address critical medical issues related to cells, tissues, and organs particularly in the treatment of severe injuries, redirect immune functions, and organ transplants. Read More..
