The Key to Successful Drug Approval: An Effective Regulatory Strategy

Author:

Seimetz Diane

Publisher

Springer Fachmedien Wiesbaden

Reference31 articles.

1. Bujar, M., McAuslane, N., & Liberty, L. (2015). New drug approvals in ICH countries 2005–2014. CIRS R&D Briefing 57, July 2015.

2. Ceretta, F. (2015). EMA Adaptive Pathways Pilot, Presentation at the Safe and Timely Access to Medicines for Patients (STAMP), November 2015.

3. EMA. (2007). Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned with an Adaptive Design (CHMP/EWP/2459/02), London.

4. EMA/109608/2014. Draft best practice guidance for pilot European Medicines Agency health technology assessment parallel scientific advice procedures, May 8, 2014.

5. EMA/339324/2007. EMA pre-authorisation procedural advice for users of the centralised procedure, January 20, 2016.

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