FDA Embassy Seminar: New Technology Challenges in Biologics
PPT Slide
History of Biological Products Regulation
Forces Impacting the Regulation of Biological Products in the 21st Century
Regulation of Biological Products Based on Sound Science, Law and Public Health Impact
Human Genome
New Discoveries:
New Discoveries: Technological advances
Analytical Challenges for Biologicals
New Discoveries: Analytical approaches
Genomics
Proteomics
Bioinformatics
New Discoveries: Therapeutic products
Gene Therapy
Xenotransplantation
Impetus for Modern Xenotransplants
Public Health Dilemma
Regulatory Issues
“Xeno-tourism”
Societal Involvement
Stem Cells
Stem Cell Safety and Potency
Combination Products – “Tissue-engineered” products
Biological – Medical Device Combination Products
Tissue Engineering - Complexities
Examples of CBER regulated biologic-device combo products
Regulation of Tissue Engineered Products
Home Page: http://www.fda.gov/oia/homepage.htm
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