Journal article

Salek et al 2012 – Scorecards to Assess the Quality of a Regulatory Submission and Its Review

An efficient review depends not only on timely approval but also on ensuring the quality of the process from construction of the dossier to the ultimate regulatory decision. Two [...]

2026-02-20T14:42:57+00:00January 1st, 2012|Tags: , |

Hirako et al 2007 – Comparison of the drug review process at five international regulatory agencies

Regulatory approval time is a key metric that is used to evaluate the performance of regulatory agencies. A new methodology has been developed to compare the regulatory review process [...]

2020-07-22T10:57:08+00:00January 22nd, 2007|Tags: |
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