Background Globally, 7,000 rare diseases affecting 300 million people pose development challenges with small patient populations. Developing medicines for rare diseases requires innovation. Despite regulatory incentives, challenges for HTA [...]
Background Pharmaceutical companies have been actively taking early scientific advice from health technology assessment (HTA) agencies during development, with the aim to understand the HTA evidentiary requirements. The evolving [...]
Introduction Over the last years, several regulatory agencies have developed risk-based approaches for the regulatory assessment of marketing authorisations of New Active Substances (NASs) as strategies to efficiently use [...]
During ISPOR Europe 2023 in Copenhagen, Belen Sola presented a poster entitled ‘Study of HTA Timelines and Outcomes for MHRA-Approved NASs in the Post-Brexit UK via Reliance/Work-sharing Routes'. Background: [...]
During the DIA Global Annual Meeting 2023, Adem Kermad, Magda Bujar and Neil McAuslane developed and presented a poster in which they shared the results, recommendations and conclusions about [...]
During the DIA Global Annual Meeting 2023, Nancy Yang-Ngum developed and presented a poster in which she shared the results, recommendations and conclusions about the topic "Evaluation of the [...]
During the DIA Global Annual Meeting 2023, Mercy Owusu-Asante developed and presented a poster in which she shared the results, recommendations and conclusions about the topic "Evaluation of the [...]
During the DIA Global Annual Meeting 2023, Lorraine Danks, Boitumelo Semete-Makokotlela, Sam Salek and Stuart Walker developed and presented a poster in which they shared the results, recommendations and [...]
During the DIA Global Annual Meeting 2023, Tariro Sithole, Nancy Ngum, Mercy Owusu-Asante, Stuart Walker and Sam Salek developed and presented a poster in which they shared the results, [...]
December's Slide of the Month is taken from a CIRS poster recently presented at ISPOR Europe 2019. Does FDA Breakthrough Designation affect HTA recommendation in terms of timing and outcome? [...]
