FDA details flexibilities for new cell and gene therapies to leverage past data

New CBER draft guidance further explains to cell and gene therapy developers the types of prior knowledge companies can leverage for clinical, nonclinical and manufacturing-related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. Topic Hubs AI drug discovery: News, analysis and interviews Antibody-drug conjugates: The next wave of targeted cancer drugs Biopharma M&A and dealmaking: Who’s buying and why Biopharma people moves: CEO changes, executive hires, board positions Biotech IPOs: Tracking the market for new public offerings Biotech venture funding: Who’s raising and where the money is going Cell and gene therapy manufacturing: Scaling the next frontier China biotech: Licensing deals and the Biosecure Act CRISPR and…

Source: Endpoints News