Zdrowie i gospodarka · 17/08/1999

FDA Releases Draft Guidance on Information Request and Discipline Review Letters Under the Prescription Drug User Fee Act

The Food and Drug Administration (FDA) has released a draft 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 the Center for Biologics Evaluation and Research (CBER) in reviewing marketing applications for certain prescription drugs and biological products.