FDA: ‘Model Master Files’ Could Support Generic Drug Development

FDA is working to create a new “model master file” approach that would allow sharing and reuse of models used in drug development in the same vein as drug master files, and officials say the tools could be especially useful in the development and approval of generic drugs. Agency officials touted the model master file framework as an equivalent to the drug master file, which would use a standing regulatory mechanism to similarly allow for generic drug companies to benefit...