14/15 December 2023
The topic of regenerative medicine therapies for diseases with serious courses has been in the FDA's focus for some time. This has also become clear through guidelines such as "Expedited Programs for Regenerative Medicine Therapies for Serious Condition". But also through the specially prepared overviews of other relevant guidelines (Resources Related to Regenerative Medicine Therapies) in this context show this attention.
For a clearer explanation of when a product or therapy is a so-called "Regenerative Medicine Advanced Therapy", the FDA has now explained this term in accordance with Section 3033 of the 21st Century Cures Act and outlined the prerequisites for this classification:
A corresponding application for the designation as "Regenerative Medicine Advanced Therapy" can already be submitted with the marketing authorisation submission of an IND or can be submitted as an addition to an already existing IND.
Further details can be found directly under "Regenerative Medicine Advanced Therapy Designation".