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2020 - FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering

Date2020-04-30 - 2020-05-01


VenueVirtual Seminar, USA - United States USA - United States

KeywordsFDA stem cell therapies; HCT/P products; Regenerative Medicine


Topics/Call fo Papers

FDA regulatory approvals for the use of stem cells in medicine (continued)
How the FDA regulates regenerative treatments and therapies
The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
The drug and biological approval process
Regenerative products as medical devices
How to design appropriate clinical trials
Applicable good manufacturing and good laboratory practices
Product labeling, marketing and advertising
FDA and other federal agency enforcement action

Last modified: 2020-03-26 00:32:28