BN Business News
Add your company to Business Communicator →

Zdrowie i gospodarka · 24.06.2019

Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Providing Regulatory Submissions in Electronic and Non-Electronic Format-- Promotional Labeling and Advertising Materials for Human Prescription Drugs." This guidance outlines the requirements and recommendations for various types of submissions of promotional materials for prescription drugs and biological products, including the specific formats needed for use in the electronic common technical document (eCTD) as well as non-eCTD and non-electronic formats. This guidance finalizes the draft guidance issued in April 2015.

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