BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 2.10.2012

Generic Drug Facilities, Sites and Organizations

The Food and Drug Administration (FDA) is notifying generic drug facilities, and certain sites and organizations identified in a generic drug submission, that they must provide identification information to FDA. This information is required to be submitted to the FDA annually under the Generic Drug User Fee Act Amendments of 2012 (GDUFA) included in the Food and Drug Administration Safety and Innovation Act (FDASIA). This notice is intended to help organizations ascertain if they need to self-identify with the FDA, determine what information they are required to submit, and familiarize themselves with the means and format for submitting the required information.

Source: Federal Register — Food and Drug AdministrationOpen original release →