21st Century Cures Act opens up doors for stem cell therapies

Written by Megan Wood | December 19, 2016 | Print  |

With President Barack Obama signing the 21st Century Cures Act into law on Dec. 13, 2016, the field of regenerative medicine and stem cell therapies stands to benefit.

The legislation positively affects the field in the following ways:

 

•    The FDA may now consider real-world evidence, allowing study data evidence of, as opposed to requiring full clinical trial records.
•    The FDA and stakeholders must collaborate on standards development.
•    Sources such as patient registries, EHRs and other collected data outside of the clinical trial process will likely play a role in the risk-benefit assessment.

 

"The 21st Century Cures Act speaks very loudly for patients with unmet clinical needs who have little or no other available treatment options," said Steven A. Brody, MD, PhD, StemGenex chief scientific officer. "Patients' voices were heard and taken seriously."

 

More articles on spine:
Titan Spine leads push for titanium interbody device resurgence through nanotechnology differentiation
Dr. Richard Morales Ozuna joins International Association of HealthCare Professionals: 5 highlights
Dr. Kenneth Pettine: Stem cell therapy is here to stay

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies here.

Top 40 Articles from the Past 6 Months