The FDA published letter to Colorado company detailing how their use of cell is the development of a new biologic drug, and, as such, require a BLA and an IND. What is also fascinating is the language within the letter. The most important, and far reaching statement in the letter is that the cells are being classified as drugs under the section 201 (g) of the Federal Food, Drug, and Cosmetic Act because the cells were not intended for autologous use.
While it is doubtful that this letter can be applied in a broader context, it does point to a continued delineation between autologous applications of cell therapies as the practice of medicine and allogeneic as drug development. This line in the sand is critical because it defends the right of the physician to apply his or her experience and expertise in treating a condition or disease, and affords a physician the right to innovate based on a one-on-one risk pyramid.
http://tinyurl.com/3ddjnhn
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