Pham et al. (2023) makes use of information on regulatory choices and well being generation exams (HTAs) in Australia, Canada, and the United Kingdom and compares them to the medicine which might be FDA-approved in america. They in finding that:

The FDA authorised 206 new medication in 2017 via 2020, of which 162 (78.6%) have been granted advertising authorization via a minimum of 1 different regulatory company at a mean (IQR) prolong of 12.1 (17.7) months following US approval. Conversely, 5 FDA-approved medication have been refused advertising authorization via a world regulatory company because of negative benefit-to-risk exams. An extra 42 FDA-approved medication gained adverse repayment suggestions from HTA companies in Australia, Canada, or the United Kingdom because of uncertainty of medical advantages or unacceptably prime costs. The median (IQR) US value of the 47 medication refused authorization or no longer really helpful for repayment via a world company used to be $115 281 ($166 690) consistent with affected person consistent with yr. Twenty medication have been for oncology indications, and 36 have been authorised via the FDA via expedited regulatory pathways or the Orphan Drug Act.

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