The U.S. Food and Drug Administration (FDA) extended the enforcement discretion policy for tissue allograft 361 regulated products from November 2020 to May 2021.
This added runway provides four additional months for companies selling 361 products to become compliant. For the past three years, FDA has consistently asked companies to file INDs for their tissue allograft products and have created a number of pathways for companies to meet with the FDA and advance their products to the clinic. One of the more effective portals for understanding how the FDA intends to regulate your company’s products is an Interact meeting.
From the FDA website: “INitial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting is an informal non-binding consultation with the Center for Biologics Evaluation and Research (CBER) at FDA. An INTERACT meeting enables sponsors to obtain preliminary informal consultation for innovative investigational products at an early stage of development on issues that are not yet at the pre-IND meeting phase.”
These links provide some solid advice on what to expect in an Interact meeting and how best to prepare.
This link has the FDA SOP for the Interact meetings.
No one has a crystal ball and can accurately predict what actions, if any, FDA plans to take come May 2021 but as the President of the Perinatal Stem Cell Society, I have been fortunate to have several conversations and meetings with the current FDA leadership and I fully believe that they understand the clinical potential of perinatal tissue and stem cell products.
I strongly urge any and all companies in the biologics field to meet with the FDA and to work to become compliant. The last thing I want to see develop in the field is that high quality manufacturers are restricted from providing patient populations in need safe perinatal tissue and stem cell products and as a result these patients are forced to try tissue products from unsafe venders and fringe operators.
I am excited to announce that the videos from the 6th International Perinatal Stem Cell Society Congress that was held March 4-6, 2020 are now live. We are committed to providing the videos of the lectures for free on our website. Enjoy!
Although you don’t need a membership to watch the videos, membership dues allow us to provide this service and to hire the videographers to capture these lectures in such high quality. Individual membership is $99 a year and corporate membership is $999.
If you would like to be considered as a speaker or would like to nominate someone for the 7th International Congress (date and location TBD) please email me directly at firstname.lastname@example.org.
Welcome to the Perinatal Stem Cell Society’s new Blog feature. The Perinatal Society was formed in 2013 and our focus was to plan and organize top notch scientific meetings. With the current status of in person meetings on hold, we have decided to launch this blog to continue to share news about the scientific developments in the field.
The true strength of the Perinatal Stem Cell Society is the members and faculty who attend the meetings and contribute to the growth and success of the society. As such, we would like to invite members of the society to help make this blog a truly powerful force for the advancement of the perinatal tissue and stem cell field.
If you would like to write a blog for the Perinatal Society please contact me directly at email@example.com.