Guidance on CMC elements for somatic cell therapy products
This article was originally published in The Gold Sheet
Executive SummaryFDA issued a guidance on CMC information for human somatic cell therapy INDs on April 10. It replaces an August 2003 draft. The review instructions and template described in the guidance are designed to help FDA reviewers in evaluating INDs for these products. The guidance contains detailed requirements for characterizing master cell banks, working cell banks and reagents. It also states that manufacturers should include a detailed description of all procedures use during the collection, production and purification of cellular therapy products
You may also be interested in...
ConMed's CFO Todd Garner told delegates at the Jefferies Healthcare conference that the company's orthopedic franchise is focused on its pipeline and meeting customer's needs. See what the CFO said about it here.
Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.
Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.