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Find similar grantsFDA Regenerative Medicine Advanced Therapy (RMAT) Designation is sponsored by U.S. Food and Drug Administration (FDA). This opportunity supports mission-aligned projects and measurable outcomes.
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Regenerative Medicine Advanced Therapy Designation | FDA Skip to in this section menu Vaccines, Blood & Biologics Cellular & Gene Therapy Products Regenerative Medicine Advanced Therapy Designation Cellular & Gene Therapy Products An update on the Cyclospora outbreak available here .
As described in Section 3033 of the 21 st Century Cures Act, a drug is eligible for regenerative medicine advanced therapy (RMAT) designation if: The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations; The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition Based on FDA’s interpretation of Section 506(g) of the Federal Food, Drug, and Cosmetic Act (as added by Section 3033 of the 21 st Century Cures Act), certain human gene therapies and xenogeneic cell products may also meet the definition of a regenerative medicine therapy.
For more information on FDA’s definition of regenerative medicine therapies, refer to the Guidance for Industry, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions . The request for RMAT designation must be made either concurrently with submission of an Investigational New Drug application (IND) or as an amendment to an existing IND.
We will not grant a RMAT designation if an IND is on hold or is placed on hold during the designation review.
You may submit a request for RMAT designation to: Food and Drug Administration Center for Biologics Evaluation and Research Office of Tissues and Advanced Therapies 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 If the RMAT designation request is submitted to your IND as an amendment, the cover letter should specify that the submission contains a REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, uppercase letters.
If the request is submitted with an initial IND, the cover letter should specify that the submission contains both an INITIAL INVESTIGATIONAL NEW DRUG SUBMISSION and REQUEST FOR REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION in bold, upper case letters.
No later than 60 calendar days after receipt of the designation request, the Office of Tissues and Advanced Therapies (OTAT) will notify the sponsor as to whether RMAT designation has been granted. If OTAT determines that the RMAT designation request was incomplete or that the drug development program does not meet the criteria for RMAT designation, OTAT will include a written description of the rationale for such determination.
Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
According to the current listing, eligibility includes: Biotech companies, Nonprofits, Universities. Confirm the full requirements in the official notice before applying.
FDA Regenerative Medicine Advanced Therapy (RMAT) Designation is funded by U.S. Food and Drug Administration (FDA). Verify program details on the funder's official page before applying.
Start from the official opportunity page linked in this listing — it carries the sponsor's submission instructions.
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