FDA Prepares for GDUFA Commitments with Controlled Correspondence Guidance

Tuesday, November 18, 2014

Source: FDA News

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the rules and specific protocol for submitting controlled correspondence to the Office of Generic Drugs (OGD) in a draft guidance published on August 27, 2014.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.

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