Healthcare Economist August 14, 2024
Jason Shafrin

What everyone wants is getting new, innovative medicines to market quickly, but at the same time insuring we have enough data to confirm that these medicines are safe and effective. How do we balance these two aims?

A paper by Ollendorf et al. (2024) provides some guidance. Some of their suggestions are summarized below.

  • Make criteria for expedited regulatory approval clear. FDA and EMA list unmet need and disease severity as key factors influencing the need for expedited regulatory approval. However, these evaluations are made qualitatively. Could we do better if we used quantitative measures such as the disability-adjusted life year (DALY) or quality adjusted life year (QALY) shortfall? Also, getting drugs to market quickly may require the use...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
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