Fall 2024 Needed Standards for the Regenerative Medicine Field
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Introduction
Thank you for participating in this survey. Your responses will remain
anonymous
. Results will only be reported in an aggregate format.
To support FDA’s Standards Recognition Program for Regenerative Medicine (SRP-RMT) products, SCB is conducting this survey to
identify standards that can promote product development and assist stakeholders in meeting regulatory requirements
for assessing identity, purity, and potency. Such standards include testing methodologies, manufacturing practices, and scientific protocols.
Your input to this survey helps to
establish the impact and urgency of the standards needs
in the regenerative medicine community. Survey results will be reflected in the
Regenerative Medicine Standards Portal
and will inform the
selection of topics for SCB-coordinated standards advancement efforts
.
This survey should take
less than 15 minutes
to complete. Please plan to
complete it in one sitting
, as you cannot save the survey and return to it at a later time.
Selected topics will undergo feasibility assessment to determine if the area is ready for standards development. If the feasibility assessment is favorable and resources allow, SCB will organize a
working group
to develop a standard around the topic.
About the Survey Format
This survey consists of two questions, each of which presents a list of standards needed by the community. In the first question, select the standards you feel are most important in terms of their potential
impact
; in the second, those that are the most important in terms of
urgency
. You may find it helpful to refer to the
needed standards summary document
as you complete the survey.
Note: Standard need
areas that have already been assessed for feasibility
are not included in this survey, but can be found in the Regenerative Medicine Standards Portal along with an overview of progress toward standardization.
What are Standards?
Standards are common rules, conditions, guidelines or characteristics for products or related processes, production methods, or management systems practices, typically developed by a non-government entity.
For more information on standards, see the
All About Standards
section of the SCB website
.
Participant Background
Please select the sector of regenerative medicine that is most relevant to your knowledge/expertise. If you have knowledge of multiple sectors, you may retake this survey for each relevant sector.
Cell therapy
Gene therapy
Tissue engineering
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