💉FDA Announces Draft Guidance for Regenerative Medicine Therapies
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft document entitled "Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry." The draft guidance document provides sponsors engaged in the development of regenerative medicine therapies for serious or life-threatening diseases or conditions with FDA's recommendations on the expedited development and review of these therapies. This draft guidance, when finalized, will supersede the final guidance of the same title dated February 2019.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The draft guidance outlines expedited development and review processes for regenerative medicine therapies targeting serious conditions, impacting compliance and regulatory requirements for businesses in the biotech and pharmaceutical sectors. This is crucial for companies seeking to innovate and address unmet needs in healthcare.