FDA Guidance for Industry
RichSource represents the RICHGEN product line biologics that are manufactured in full compliance at a FDA registered tissue processing labs. The biologics are regulated as human cellular or tissue-based product (HCT/P) under 21 CFR Part 1271.10 and Section 361 of the Public Health Service Act, FDA and ISO 13485 guidelines. FDA, AATB, cGMP and cGTP compliant. The extracellular vesicles FDA IND applications are continuously in process and being submitted for a variety of clinical trials. Additional FDA IND applications are in process for submission shortly. Note that the FDA has extended the guidance section V. for minimally manipulated products until May 31, 2021.
