Recently Posted Guidance Documents

Recently Posted Guidance Documents

6/13/2019 Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act  6/13/2019 Mouse Embryo Assay for Assisted Reproduction Technology Devices 6/13/2019 Testing for Biotin Interference in In Vitro Diagnostic Devices: Draft Draft Guidance for Industry 6/12/2019 ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry 6/12/2019 Applications for Premarket Review of New Tobacco Products 6/12/2019 Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry