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# FDA Regenerative Medicine Framework is ‘Important Step’: Pew
- URL: https://www.fdaweb.com/fda-regenerative-medicine-framework-is-important-step-pew/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:29.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5145361

A Pew Trusts report, “FDA’s Framework for Regulating Regenerative Medicine Will Improve Oversight,” says the agency’s 2017 guidance documents that constitute its regulatory framework “marks an important step in the agency’s efforts to encourage the development of new therapies while also protecting patients from dangerous unapproved interventions.” The [report](https://www.pewtrusts.org/-/media/assets/2019/10/fdasframeworkforregulatingregenerativemedicine%5Fv2.pdf?ref=fdaweb.com) says that while FDA has made progress in implementing components of the framework, it remains to be seen what the impact will be on the regenerative medicine industry and on the successful development of safe, effective, and innovative new therapies.

According to Pew, the framework aims to **(1)** clarify the distinctions between products that are subject to the agency’s full drug approval requirements and those that are not; and **(2)** streamline the review process for new therapies and reduce some of the regulatory requirements on product developers.

The report, Pew says, is based on a commissioned legal analysis; interviews with experts from the legal, scientific, clinical, bioethics, and advocacy field; and a review of the related literature. Key findings it presents are: 

- stakeholders generally believe that the FDA framework provides important clarity on how the agency will regulate regenerative therapies and will have a significant impact on the trajectory of the field;
- some areas of ambiguity and controversy remain, especially over whether the agency has appropriately defined the fundamental concepts that determine whether a product will be regulated as a drug and/or medical device;
- the regenerative medicine advanced therapy expedited development pathway established by the 21st Century Cures Act increases the burden on FDA to enforce post-approval study requirements to confirm that products are safe and effective;
- nearly all stakeholders expressed doubt that the agency has the resources to fully enforce the framework, particularly regarding the hundreds of clinics that market unapproved stem cell interventions; and
- other state and federal public health stakeholders can play a key role in limiting the ability of businesses to market unapproved interventions.

Pew says that going forward, clear and timely communication will be important to FDA success, including communication on decisions about how it will classify human cells and tissue products and, as appropriate, updating or finalizing relevant guidance documents. It also calls for enforcement activities such as Warning Letters or injunctions and product seizures against the hundreds of providers offering unapproved stem cell interventions in the U.S.