Newsletter - April 26, 2018
FDA Gives and FDA Taketh Back: Rescinding Breakthrough Designation
Since the inception of the Breakthrough Therapy Designation (BTD) program over 5 years ago, FDA granted this designation to 63 products, and approved 17 products under this program. But it also took back the designation from 14 of them, 5 in last year alone....Read More
Senator’s 7 Questions to FDA about Stem Cell Clinics: Politics of Stem Cells
Last week Senator Chuck Grassley of Iowa sent a letter to FDA asking about the outcome of a Warning Letter issued last year to a stem cell clinic and in the process raised issues that could affect regulation of all similar clinics by FDA. In August 2017, FDA issued a Warning Letter to US Stem Cell for several violations of GMP....Read More
FDA Gives and FDA Taketh Back: Rescinding Breakthrough Designation
Since the inception of the Breakthrough Therapy Designation (BTD) program over 5 years ago, FDA granted this designation to 63 products, and approved 17 products under this program. But it also took back the designation from 14 of them, 5 in last year alone....Read More
Senator’s 7 Questions to FDA about Stem Cell Clinics: Politics of Stem Cells
Last week Senator Chuck Grassley of Iowa sent a letter to FDA asking about the outcome of a Warning Letter issued last year to a stem cell clinic and in the process raised issues that could affect regulation of all similar clinics by FDA. In August 2017, FDA issued a Warning Letter to US Stem Cell for several violations of GMP....Read More
