Future FDA guidances
This article was originally published in The Tan Sheet
Executive Summary
CDER expected to release guidance documents pertaining to OTC labeling, OTC labeling comprehension studies, OTC actual use studies, manufacturing issues for ophthalmic drug products and "The Small Entity Compliance Guidance On: Regulations for the Labeling of Over-the-Counter Human Drugs," according to the semiannual guidance document agenda published in the Nov. 15 Federal Register. CFSAN may publish two guidances pertaining to dietary supplements: one containing supplement Q&As and one on identity testing guidelines