Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guideline
The drafting of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) is intended in order to address and to avoid potential pitfalls in drug development.
The adopted reflection paper intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products for the treatment of patients with PBC and PSC.
Keywords: non-alcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), clinical trial designs, endpoints, conditional licensing, unmet medical need, liver biopsy
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