Short Report: FDA Public Hearing, November 16-17, 1995 <META NAME="GENERATOR" CONTENT="Microsoft FrontPage 4.0">

Short Report: FDA Public Hearing, November 16-17, 1995

On November 16 and 17, 1995, the Food and Drug Administration held a public hearing regarding "Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for the Structural Repair and Reconstruction". The autologous cell technology discussed at this hearing involves the removal of cells from a patient, expanding them in culture without altering their biological characteristics, and re-implanting them in the patient from which they were taken at the site of removal or at a different location in the body. This hearing was an open forum among the Agency, industry and the general public to discuss how autologous cell technology is currently being used and to what extent, if any, the FDA should have regulatory oversight.

For a full report on the Public Hearing, contact AccuReg at accureg@regulatory.com and request a copy of the December 1995 issue of The Regulatory Forum News by snail mail, at no charge.

For those who are interested in learning more about recent regulatory developments affecting biological products, including issues:

Covered at the November 16-17 public hearing
Identified in the Clinton Administration's report entitled, "Reinventing the Regulation of Drugs Made from Biotechnology,"
Discussed in a workshop sponsored by FDA and the Massachusetts Biotechnology Council, and
Addressed at FDA's recent workshop on December 11-13 entitled, "Characterization of Biotechnology Pharmaceutical Products"

AccuReg can generate a detailed summary report for a moderate Service fee. Contact Diana Baldwin at accureg@regulatory.com if you are interested.

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