On Tuesday, February 11, Ed Allera and Barbara Binzak Blumenfeld, members of Buchanan Ingersoll & Rooney’s FDA Section, traveled to San Antonio to present on FDA’s regulation of cells and tissues.
The teams in-depth presentation included areas of consideration and concern for all companies venturing into the cell and tissue therapy market sector, including product jurisdiction issues, possible FDA regulatory pathways, legal challenges to FDA cell and tissue regulation decisions, payments for cell and tissue therapy products in development, and insurance coverage for such products.
Cell and tissue therapies are one of the more rapidly-growing areas in basic research and development and patient treatment. As a result, regulatory oversight of these therapies is likely to be a highly-evolving area of FDA focus for years to come.
Because this market sector is advancing so quickly, Buchanan’s FDA team has assembled a deep knowledge base in this area and has the ability to review each client’s cell and tissue therapy issues from all possible legal and regulatory angles. For our clients, we have prepared a definitive primer on cell and tissue regulation, including all the issue-areas mentioned above. The team can also present the primer to potential clients in order to help them better understand the legal and regulatory landscape and assess their needs going forward.