Recently Posted Guidance Documents on Food Safety Modernization Act (FSMA); Combination Products, Postmarket; Compounding

Compounding

3/23/2018 Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

Combination Products, Postmarket

3/21/2018 Postmarketing Safety Reporting for Combination Products

3/21/2018 Compliance Policy for Combination Product Postmarketing Safety Reporting

Food Safety Modernization Act (FSMA)

3/20/2018 Draft Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507