Gail Javitt Quoted in “Stem Cell Court Win for FDA Is Start of a ‘Marathon’ Fight”Bloomberg Law June 6, 2019
Gail H. Javitt, Member of the Firm, in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Law, in “Stem Cell Court Win for FDA Is Start of a ‘Marathon’ Fight,” by Jeannie Baumann.
Following is an excerpt:
The Florida district court decision validates FDA’s interpretation of its regulatory framework for therapies involving human cells or tissues, said Gail H. Javitt, an attorney with Epstein Becker Green whose specialties include the FDA’s regulation of cell products.
The FDA’s interpretation has been around for almost two decades, but its contours have received more attention as scientific advances have led to increased interest in using cells and tissues in new therapeutic ways, Javitt said.
“The boundaries between ‘traditional’ and ‘novel’ have been blurred,” she said.