US FDA published a notice in the Federal Register announcing the availability of a new draft guidance for industry, titled Controlled Correspondence Related to Generic Drug Development.
This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development. This guidance also describes FDA’s process for providing communications related to such correspondence. FDA is issuing this draft guidance as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.
EP News Bureau– Mumbai
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