Resources

To submit a filing to the FDA, whether that be an NDA, ANDA, or 505(b)(2), a product owner must provide technical files containing a pharmaceutical product's chemistry, manufacturing, and control (CMC), safety (nonclinical), and efficacy (clinical) testing results before gaining approval and market access. This includes analytical testing procedures for the drug substances and the finished...

Turning a promising drug candidate into a successful pharmaceutical product involves scaling-up the processes, developed in the research lab, in order that commercial supply can be achieved. The technical hurdles involved in making this transfer can be daunting. Also, it is not uncommon for changes to be made in the manufacturing process and/or chemistry of a drug product following approval and...