Draft Guidance for Industry on the Food and Drug Administration's “Drug Watch” for Emerging Drug Safety Information; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "FDA's `Drug Watch' for Emerging Drug Safety Information." This document provides guidance about how FDA intends to develop and disseminate important emerging drug safety information concerning marketed drug products to healthcare professionals and patients. This information will appear on an FDA Web page to be called the "Drug Watch."