💊FDA Issues Draft Guidance for Developing Drugs for Erosive Esophagitis
Erosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults,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, trial design features, efficacy evaluations, and safety assessments.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's draft guidance on developing drugs for erosive esophagitis establishes regulatory standards that pharmaceutical companies must follow, impacting drug development timelines, trial costs, and market entry strategies. These guidelines could affect compliance requirements and financial planning for related businesses.