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Awareness of FDA Science Requirements in Support of Breakthrough Regenerative Medicine Technologies

 Peter C. Johnson MD
  25th-Aug-2016
Description: Stem Cells Vs. Tissues Per Se: Stem Cells, Tissues- Minimally manipulated, autologous, Minimally manipulated, for homologous allogenous use, More than minimally manipulated (where your capacity to impact patient care begins to be restricted). Therapeutic Issues: Autologous/Allogenous, Degree of manipulation, Intended use application, Safety/Efficacy, Infectious Disease. FDA Tissue Rules: HCT/Ps- Articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.
Views: 1011
Domain: Medical
Category: Biotech/Pharma
Contributing Organization: World Stem Cell Summit
 ‐ More of their Presentations
Contents:
Awareness of FDA Science Requirements in
Support of Breakthrough Regenerative
Medicine Technologies

The Playing Field
Rogue
Presently
Allowable
Practices

P

Future
Allowable
Practices*

Practices
*A Function of the growth of scientific understanding
And ethical patient advocacy.

Awareness of the Role of Science in the FDA
Regulatory Submission Process:
A Survey of the TERMIS-Americas Membersh ... See more

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