![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FDA Issues Recommendations for Esophagitis Drug Trials
FDA Issues Recommendations for Esophagitis Drug Trials
February 12, 2019
The FDA released draft guidance on clinical trial designs for treatments of eosinophilic esophagitis (EoE), a chronic inflammatory disease, including recommendations for selecting trial participants.
The randomized, double-blind, placebo-controlled trials should include a prespecified screening period before patients are randomized to confirm their eligibility, the agency said.
Trials conducted to support a drug’s marketing approval should evaluate the drug’s effect on both symptoms and the underlying inflammation of the disease by assessing the coprimary endpoints in Phase 3 trials.
Upcoming Events
-
21Oct