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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:
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:
If you’re involved in HCT/Ps, regenerative sciences or support this industry, you must attend this upcoming webinar! Particularly:
Dr. Stacie Ropka, Of Counsel, for Axinn, Veltrop & Harkrider LLP holds a PhD in Microbiology and Immunology. Her practice is focused on IP litigation, due diligence and client counseling with an emphasis on the life sciences, biologics and biologic-based pharmaceuticals. Stacie keeps abreast of the technology and related law by regularly attending both scientific and legal conferences. Prior to attending law school, Stacie held a faculty position at SUNY Upstate Medical University. She also spent many years as a research scientist in the fields of neurology, virology and immunology, both at Northwestern University and SUNY Upstate Medical University, and has presented her original research at numerous scientific conferences. Stacie is a member of the American Bar Association, The American Society for Microbiology and The Antibody Society.
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