Zdrowie i gospodarka · 21/11/2001

FDA Releases Guidance on Information Request and Discipline Review Letters Under Prescription Drug User Fee Act

The Food and Drug Administration (FDA) has made available a document providing guidance to the pharmaceutical industry on the use of specific letters by the FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) in reviewing marketing applications for certain prescription drugs and biological products, following the finalization of a draft guidance document from 1999.