Pharma Blog Watch

FDA Prepares for GDUFA Commitments with Controlled Correspondence Guidance (Weinberg on FDA Blog)
With the implementation of GDUFA, FDA defined the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27, 2014. Though controlled correspondence has been a staple of generic drug development for many years, this guidance iterates, seemingly for the first time, the definition of controlled correspondence. Blogger Emily Krulewitz explains.