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2018 - FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)



VenueOnline event, USA - United States USA - United States

KeywordsContent="HCT/Ps; FDA HCT/Ps; Tissue Guidances; 361 HCT/P; 21 CFR Part 1271; 1271


Topics/Call fo Papers

Provide an overview for preclinical and clinical development phase for HCT/Ps
Discuss fundamentals of HCT/Ps development and regulatory requirements
Provide an overview for FDA’s regulatory approvals process for HCT/Ps
Discuss FDA guidance documents and most recent policies updates for regenerative medicine and stem cell technologies
Applicable good manufacturing and good laboratory practices
Product labeling, marketing and advertising
Discuss post-licensure requirements

Last modified: 2018-06-30 17:35:38