New drugs approval

Risks in new drug development: approval success rates for investigational drugs.

Getting approval for new therapeutic medical devices versus drugs: are the differences justified?

In the so-called evidence-based medicine (EBM) era, pre-market clinical trials showing equivalent or superior benefit from new drugs versus existing therapies are required by regulatory bodies, while the process for approval of medical devices is less stringent [1]. The expansion of device-based therapies for cardiovascular conditions makes cardiology the ideal setting for analysing the peculia...

Drug approval decision times, international reference pricing and strategic launches of new drugs

This paper analyzes how drug approval procedures in uence the incentives of pharmaceutical rms to launch new drugs in the presence of international reference pricing. First, we show that the set of countries in which a rm commercializes a new drug is larger when countries do not approve this new drug simultaneously. We also show that a rm's best response to international reference pricing is to...

Re-examining our approach to the approval and use of new drugs.

Rethinking the Appraisal and Approval of Drugs for Fracture Prevention

Background: In January 2014, the EMA's Pharmacovigilance Risk Assessment Committee recommended that strontium ranelate no longer be used for osteoporosis. However, EMA's Committee for Medicinal Products for Human Use decided to restrict its use rather than ban it. Starting from this fact, evidence of drugs for fracture prevention over the last 30 years was reviewed and lessons to be learnt from...