WASHINGTON, Sept. 17 -- Food and Drug Administration has issued a notice called: Erosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability.
The notice was published in the Federal Register on Sept. 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, tria...