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Our results show some similarities and differences in the approvals of PM drugs among the three regions of the ICH.
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The U.S. Food and Drug Administration, which regulates all prescription drugs and devices, has now issued an Action Plan which presumably will incorporate to some degree the study of sex differences in the approval process for drugs and devices.
For this reason the number of treatments accessible for male osteoporosis is fewer than in women and differences in the approval of drug use for men are present between some geographic areas (eg, teriparatide is not available for men in Europe).
In fact, a study conducted for the state three years ago found that finger imaging made no difference in the approval or dropout rates of welfare recipients.
Collecting data from government agencies can be challenging, so having relationships with appropriate contacts can also make a difference in the approval process.
Vaccines against seasonal influenza, H1N1 influenza and H5N1 influenza, were excluded due to significant differences in the FDA approval process of influenza vaccines.
These results are compatible with previous studies from other countries regarding differences in the prevalence of approval between WLPT and EUT [ 11, 12, 14, 15, 18].
The differences in orphan drug approvals between the EU and the USA may therefore be best explained by the maturity of the US pharmaceutical and biotech industry compared to Europe.
To accurately compare the outcome between a new drug and an existing one, differences in the calendar year of drug approval should be considered.
Take a look at the differences in estimated historical approval on and in the month following election day.
These guidelines recognize country differences in drug approval and availability, and offer different options where appropriate [22].
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