Home » EMEA Outlines Requirements for GERD Drug Studies
EMEA Outlines Requirements for GERD Drug Studies
January 14, 2010
The European Medicines Agency (EMEA) recommends that sponsors testing gastroesophageal reflux disease (GERD) treatments for reflux esophagitis in Phase
III trials use a primary endpoint of complete healing of mucosal breaks. Includes the full text of EMEA Draft Guidance on GERD Drug Development.
To View This Article:
Subscribe To International Pharmaceutical Regulatory Monitor