US Stem Cell Inc (USRM)

[bluesbrothers]

No later than 60 calendar days after receiving the designation request, FDA’s newly created Office of Tissues and Advanced Therapies (OTAT) will notify the sponsor if the designation has been granted. If the RAT designation request is incomplete or the drug development program does not meet the criteria for designation as a regenerative advanced therapy, OTAT says it will include a written description of the rationale for such determination.

Regenerative Advanced Therapy Designation

- See more at: http://www.raps.org/Regulatory-Focus/News/2017/01/20/26651/FDA-Begins-Accepting-Regenerative-Therapy-Applications-for-RAT-Designation/#sthash.nBLsHUdP.dpuf