Zdrowie i gospodarka · 31.01.2001
Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format, Prescription Drug Advertising and Promotional Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Prescription Drug Advertising and Promotional Labeling." The draft guidance discusses how to submit promotional materials in electronic format to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This draft guidance is one of a series of guidances being developed by the agency to assist applicants who wish to make regulatory submissions in electronic format. Although submissions in electronic format are voluntary, the agency encourages them as a way to improve the efficiency of handling and reviewing documents and data.