New CBER draft guidance further explains to cell and gene therapy developers the types of prior knowledge companies can leverage for clinical, nonclinical and manufacturing-related work.
The FDA is further explaining to cell and gene therapy developers the types of prior knowledge companies can leverage for clinical, nonclinical and manufacturing-related work …
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FDA draft guidance outlines what drugmakers can and can't tell insurers about unapproved products, with real-world evidence…
It’s a crucial moment for the cell and gene therapy field. At the American Society of Gene & Cell Therapy’s annual meeting,…
The FDA has issued draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer…
US regulators are willing to reconsider using a Phase 3 study of tab-cel as the basis for an approval, after previously rejecting…
The FDA is looking to get thrifty with its approved drugs. | The framework would leverage existing safety data on approved drugs…
All of the regular ASCO abstracts dropped Thursday afternoon. Find updates on potential successors for Pfizer’s blockbuster…
