LOS ANGELES, July 27, 2017 — Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing biological therapies for Duchenne muscular dystrophy (DMD) and other rare diseases, today announced that it has received official minutes of the meeting held recently between the U.S. Food and Drug Administration (FDA) and Capricor to discuss the development of intravenous CAP-1002 (allogeneic cardiosphere-derived cells) for the treatment of Duchenne muscular dystrophy (DMD).
U.S. FDA Accepts Biological Industries’ Drug Master File for NutriStem® hPSC Xeno-Free Medium
Recently, Biological Industries (BI) submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for purposes of moving its NutriStem® hPSC XF Medium toward being certified for clinical applications. The product is a defined, xeno-free (XF), serum-free (SF) medium that supports the growth and expansion of human induced pluripotent stem (iPS) and embryonic stem cells (ESCs). [Read more…]
How are Stem Cells Regulated by the FDA?
On September 12-13th, 2016, the FDA hosted a public hearing to review draft guidances pertaining to the FDA regulation of stem cells.
More specifically, the hearing addressed the regulation of human cell and tissue-based products (HCT/Ps), defined by the FDA in § 1271.3(d) as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” [Read more…]
Are You Planning to Attend FDA’s September 8th Public Workshop on Development of Cellular and Tissue-Based Products?
The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” [Read more…]
Will You Be Attending? FDA Reschedules Part 15 Public Hearing for September 12-13 (5 Month Delay)
Recently, we explored the overwhelming response received by the FDA for participation in its Part 15 Hearing intended to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products.”
With approximately 600 registrations and 100 people interested in presenting, it was clear that individuals across country are concerned about these draft guidances that appear to be a further restriction on stem cell therapy within the U.S.
As a result of this massive registration response, the FDA cancelled the original April 13, 2016, hearing date and announced that it would be rescheduled for an undetermined date. [Read more…]