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- FDA advises early engagement and error prevention for BLA submissions, says CBER expertA CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…
- Regenerative medicine requires diagnostics and product characterization beyond stem cell basicsStem cell therapies are often portrayed as a single treatment, but they actually vary widely in tissue source, cell passage, viability and delivery methods. Experts say a credible regenerative app…