Zdrowie i gospodarka · 22/04/2015

FDA Releases Draft Guidance on Promotional Labeling and Advertising Materials for Human Prescription Drugs

The Food and Drug Administration (FDA) has published a draft guidance outlining the requirements for submitting promotional materials for human prescription drugs, including electronic and non-electronic formats, to the Office of Prescription Drug Promotion (OPDP) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER).