Guidance for Industry

Docket Number: FDA-2023-D-1954 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original...

Drug Trials Snapshots: EKTERLY

HOW TO USE THIS SNAPSHOT The information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, and whether there were differences among sex, race, age, and ethnic groups. The “MORE INFO” bar...