Economic Analysis of Risk and Uncertainty Induced by Health Shocks: A Review and Extension
473
safety in 1963 but did not require proof of efficacy before sale until 1971 (Grabowski
et al., 1978). The UK also had shorter review times than the US, at least until the pas-
sage of PDUFA in 2002. For example, in 1980, total development times (including
preclinical testing, clinical testing and regulatory review times) were 145 months in the
US versus just 70 months in the UK (Thomas, 1990).
Tables 8.1–8.3 summarize research on the effects of FDA regulation on three impor-
tant sets of outcomes. Table 8.1 focuses on innovation and includes outcomes such ...
Become an O’Reilly member and get unlimited access to this title plus top books and audiobooks from O’Reilly and nearly 200 top publishers, thousands of courses curated by job role, 150+ live events each month, and much more.