HCT/P: FDA’s Newest Regulatory Battleground - Webinar CD/Transcript
HCT/P: FDA’s Newest Regulatory Battleground – How FDA’s Tissue Guidances Will Impact Manufacturers and Users
Get an exclusive analysis of the FDA oversight of HCT/Ps with a focus on what the draft guidelines mean to you.
On Dec. 22 and 23 the FDA released two important guidances regarding the management of human cells, tissues and cellular/tissue based products (HCT/P). The guidances were:
- Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products -Draft Guidance
- Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations-Draft Guidance
Two small words “minimal manipulation” are raising serious – potentially enormous -- concerns for manufacturers, affiliated companies, healthcare providers, research organizations, physicians and others involved in regenerative sciences.
Are you now under the FDA’s direct regulation?
Depending on how you manage HCT/Ps you now may fall under FDA’s direct regulatory oversight. If so, these draft guidances will require you – for the first time – to potentially file new drug or device applications, conduct clinical trials, comply with cGMP and QSR regulations and applicable post market surveillance requirements.
While these guidances were welcomed by HCT/P manufacturers, affiliated companies, healthcare providers, research organizations and physicians, for some these guidances will dramatically impact their operations and finances.
This presentation will teach you:
- The FDA’s position on when a HCT/P constitutes a drug/device and what resulting requirements need to be fulfilled
- How the courts have interpreted “minimal manipulation” and how you may be in violation given their existing processes
- What processes in the draft guidances constitute some of the acceptable forms of minimal manipulation (i.e. rinsing, cleaning (or cleansing), sizing, shaping)
- What processes (aka manufacturing steps) previously found to be acceptable meet the new standard of minimal manipulation; what’s in and what’s out?
- How you can influence the draft guidances and what possible areas of the guidances the FDA will revise.
- What the regenerative sciences decision means for the rapidly growing field of adipose tissue