Zdrowie i gospodarka · 14/05/1998

FDA Releases Guidance on Classifying Resubmissions in Response to Action Letters

The Food and Drug Administration (FDA) has published a guidance document outlining its procedures for classifying resubmissions of new drug applications (NDAs) and license applications (LAs), as well as its response timeframes, and is seeking public comments on the document, with a deadline of August 12, 1998.