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Drugs were categorized as orphan drugs using the FDA's monthly drug approval reports database and the FDA's orphan drug list.
22 Briefly, we scoured the Drugs@FDA monthly drug approval reports database (including original new drug approvals and biologic license application approvals) and the FDA's annual reports summarizing new molecular entities and new biologics spanning 1999 to 2014.
Drugs were categorized as priority review using the FDA's annual priority approval reports, the Drugs@FDA database, and information provided by the FDA under the Freedom of Information Act.
30 A few drugs not listed as orphan drugs in the Drugs@FDA monthly approval reports were listed as having received an orphan designation in the FDA's orphan drug list; the orphan drug list was considered to be more authoritative if the difference could not otherwise be explained.
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In accordance with the Central Denmark Region Committees on Biomedical Research Ethics the study needed no further approval (Report no. 128/2010).
Study quality was evaluated using 11 characteristics: ethical approval reported, eligibility criteria described, definition of cohort timing provided, demographics described, comorbidities reported, severity of illness score reported, study duration reported, completeness of follow-up, adjustment for potential confounders, sample size calculation reported and study limitations reported.
The fall in approvals, reported by the Bank of England, was larger than expected and comes as Threadneedle Street moves to take some of the heat out of the market.
Secondly, and more fundamentally, the appreciable rise in mortgage approvals reported by the Bank of England in June fuels uncertainty as to whether the recent loss of momentum in housing market activity is likely to be lasting or just a temporary development related to changing mortgage regulations.
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CEO of Professional Science Editing for Scientists @ prosciediting.com