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The field of regenerative medicine is expanding exponentially and the use of perinatal tissue derived products is a major driving force behind this growth.
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Industry Standards
Perinatal Tissue Derived Products are Regulated
The field of regenerative medicine is expanding exponentially and the use of perinatal tissue derived products is a major driving force behind this growth. Perinatal tissue derived products are regulated like all human cells and tissue products HCT/Ps are regulated by the FDA in tiered risk-based approach and are either regulated under section 361 of the Pubic Health Service Act (PHS Act) or the product is treated as a drug and regulated under section 351of the PHS Act. In addition to the PHS Act the FDA has published a series of Guidance Documents to provide further clarification on how the FDA plans to interpret the law in regards to HCT/Ps.
We Are Working to Improve the Current Regulation Paradigms
It is the view of the Perinatal Stem Cell Society that the current regulation paradigms for HCT/Ps are not adequate to address the revolutionary growth in the use of perinatal derived tissue and stem cell products taking place in the United States and throughout the world. As such, we feel that it is incumbent on the industry and clinicians working in the field to self regulate in order to provide only the safest and most efficacious products to the public.
As the Perinatal Stem Cell Society is comprised of the many of the world’s leading researchers and clinicians, we have decided to form a working group of industry representatives and society members to develop voluntary guidelines for manufacturers producing 361 regulated perinatal derived tissue and stem cell products.
The field of regenerative medicine is expanding exponentially and the use of perinatal tissue derived products is a major driving force behind this growth. Perinatal tissue derived products are regulated like all human cells and tissue products HCT/Ps are regulated by the FDA in tiered risk-based approach and are either regulated under section 361 of the Pubic Health Service Act (PHS Act) or the product is treated as a drug and regulated under section 351of the PHS Act. In addition to the PHS Act the FDA has published a series of Guidance Documents to provide further clarification on how the FDA plans to interpret the law in regards to HCT/Ps.
We Are Working to Improve the Current Regulation Paradigms
It is the view of the Perinatal Stem Cell Society that the current regulation paradigms for HCT/Ps are not adequate to address the revolutionary growth in the use of perinatal derived tissue and stem cell products taking place in the United States and throughout the world. As such, we feel that it is incumbent on the industry and clinicians working in the field to self regulate in order to provide only the safest and most efficacious products to the public.
As the Perinatal Stem Cell Society is comprised of the many of the world’s leading researchers and clinicians, we have decided to form a working group of industry representatives and society members to develop voluntary guidelines for manufacturers producing 361 regulated perinatal derived tissue and stem cell products.
As the Perinatal Stem Cell Society is comprised of the many of the world’s leading researchers and clinicians, we have decided to share voluntary recommendations for manufacturers producing 361 regulated perinatal derived tissue and stem cell products.
Perinatal Stem Cell Society (PSCS) Advisory
Recommendations for Perinatal Tissue Product(s) Safety and Quality
Perinatal Stem Cell Society (PSCS) Advisory
Recommendations for Perinatal Tissue Product(s) Safety and Quality
We Invite You to Join Us!
If you are a stakeholder in the perinatal field and would like to join this working group,
please email the President of the Perinatal Stem Cell Society directly at kyle.cetrulo@perinatalstemcells.com
please email the President of the Perinatal Stem Cell Society directly at kyle.cetrulo@perinatalstemcells.com
For more information:
PHS Act and the Guidance Documents
PHS Act and the Guidance Documents
