|  FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | FDA Issues Final Guidance on Electronic Postmarketing Safety Reports The U.S. Food and Drug Administration has issued the final guidance, Providing Submissions in Electronic Format – Postmarketing Safety Reports. This final guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. This guidance is intended for any party with postmarketing safety reporting responsibilities for approved and unapproved human drug products and licensed biological products, except for vaccines. FDA issued a revised draft version of this guidance in June 2014. The agency made minimal changes in the final guidance, clarifying and updating topics included in the draft guidance on how to submit postmarketing safety reports that FDA can process, review, and archive. The final guidance also provides recommendations on how to submit postmarketing safety reports that FDA can process, review, and archive for other categories of products, including compounded and combination products. | | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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