A look at the FDA’s long-awaited guidelines on how it will regulate regenerative medicine products, including stem cells.
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FDA announced its long-awaited guidelines on how it will regulate regenerative medicine products, including stem cells. The framework offers companies guidelines on how certain “minimally manipulated” products could be used without formal approval as well as guidance on how homologous applications will be regulated. It doesn’t directly address the number of shady “stem cell clinics” hawking unproven and potentially dangerous therapies, but FDA does appear to be cracking down on some of those. -KT
Here’s a roundup of these stories and other top legal news from the past month.
- FDA Announces Comprehensive Regenerative Medicine Policy Framework
- BioMarin Sells Second Rare Disease Priority Review Voucher for $125M
- Pfizer and Genentech Duke it Out in Court Over Herceptin Biosimilar Patents
- Senate Committee Holds Hearing on CRISPR Science, Ethical Concerns, Regulatory Approaches
- FDA Cracks Down on Stem Cell Clinics
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