Earlier this year, the FDA announced it would hold a hearing on cell therapy, originally scheduled for April 13, 2016. However, due to overwhelming public interest, the FDA decided to postpone the meeting. Now, finally, that time for the meeting has come.
Taking place over two days later this month (September 12 and September 13, 2016) at the NIH campus in Bethesda, MD, the meeting is officially dubbed a “Public Hearing.” The impetus behind this hearing is to provide comments to the FDA about the draft guidances issued recently. In the FDA’s own words, the purpose of the hearing is:
“[…] to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). […] FDA would like comments on the scope of the four draft guidances, including the particular topics covered, the particular questions posed, whether there are additional issues for which guidance would be helpful.”
Open to the public as well as researchers involved in stem cell-based work, it is unofficially said the FDA is also curious about receiving feedback so that it can better assess the state of the industry in order to provide greater oversight of stem cell clinics operating in the country.
The meeting comes on the heels of the latest guidances, issued in late 2015, on the
Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products.
Registration was closed on July 1st, 2016 – and while the previous hearing, that took place in October 2015, featured over 50 speakers which were given either 3 or 6 minutes of “talk time,” this meeting is expected to far surpass the previous one in attendance due to it taking place over two days.
The FDA will make the meeting available via Webcast from their website, so for those of you who haven’t managed to register, here is your chance.
For more information on the hearing, go here.
We will be following the meeting, and – as we continuously closely follow regulatory developments in the cell therapy field – will report on any industry-wide relevant updates.