FDA steering on ANDA submissions

FDA steering on ANDA submissions

FDA steering on ANDA submissions

With the US Generic Drug Person Price Amendments (GDUFA) reauthorized
by Congress on September 30, 2022, referred to as GDUFA III, these
provisions are in impact October 1, 2022, by means of September 30,

The US Meals and Drug Administration (FDA) stated on Friday that it
is dedicated to making sure present and potential abbreviated new
drug utility (ANDA) candidates have the knowledge they want
to efficiently submit high-quality ANDAs all through the GDUFA…

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