On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).

By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two new guidance documents clarify the PMSR requirements that apply when a product is comprised of multiple medical categories. According to the FDA, these documents were issued in an effort to further interpret the Final Rule by ensuring consistent and complete reporting while simultaneously avoiding duplication in reports.
Continue Reading FDA Provides Guidance on Postmarketing Safety Reporting for Combination Products

This week, the U.S. Food & Drug Administration (FDA) published draft guidance, describing FDA’s policy and process for evaluating bulk drug substances used in compounding by outsourcing facilities that are registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 
Continue Reading FDA’s New Draft Guidance on Bulk Drug Substances in Compounding