Exact(4)
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.
Similar(55)
The conditional approval report for a 50-megawatt plant in Russell, Massachusetts, says that operators expect to buy 250,000 to 350,000 green tons a year of "whole tree fuel".
A "justification and approval report" was not completed until a month after the lease was signed, but documents were pre-signed or altered to make it appear that the leasing authority was in place, the report said.
The swing into positive territory happened when 79 percent of workers at a plant in Flat Rock, Mich., voted in favor of the contract, according to the Web site of Local 3000 there; that is the largest margin of approval reported publicly so far.
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.
11 12 14 19 We also examined trends over time in reporting ethical approval, reporting individual consent and quality of the consent processes, using logistic regression or ordinal logistic regression as appropriate, testing for assumptions of the models as appropriate and using a 5% significance level in all analyses.
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.
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