The Food and Drug Administration (FDA) just released draft Guidance for Industry – Controlled Correspondence Related to Generic Drug Development (Draft Guidance) to address the improvements promised by the Generic Drug User Fee Amendments of 2012 (GDUFA), Public Law 112-144, Title III.
Under the GDUFA, FDA was tasked with using fees to improve critical aspects of FDA's generic drug review program. These improvements include goal dates in which FDA must respond to so-called "controlled correspondence."
Controlled Correspondence essentially consist of a variety of questions, on a specific element of generic drug product development that are posed as 'controlled documents,' that are asked by pharmaceutical firms and related industry.
The Draft Guidance addresses many of the procedural issues associated with controlled correspondence, for example, how such correspondence should be submitted to FDA. Additionally, FDA included a number of topics that are outside of the scope of the Draft Guidance. These include pending abbreviated new drug applications (ANDAs).
Comments on the Draft Guidance will be accepted by FDA for 60 days from August 27, 2014. FDA has also released a pre-recorded Webinar and presentation slides on this topic.
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