[The new German drug market law AMNOG from a child and adolescent psychiatry perspective].

CONCLUSION: Clearly differing requirements for study designs and outcome parameters characterize the conditions for market authorization and for the assessment of benefits. Further adjustments to the regulations in implementing the AMNOG appear to be essential, integrating agencies involved so far, complimented by expertise from regulatory agencies and medical scientific societies. PMID: 26992908 [PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/26992908?dopt=Abstract

Source: Der Nervenarzt - March 18, 2016 Category: Neurology Authors: Dittmann RW Tags: Nervenarzt Source Type: research