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New drug applications were less likely than licensing applications for biologics to have press releases associated with complete response letters (relative risk 0.79, 95% confidence interval 0.66 to 0.95); all biologics licensing applications had associated press releases.
The recent European Union Regulation on Medicines for Paediatric Use requires studies in neonates to be included in licensing applications for medicines that could be used in the newborn.
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A few years ago, the commission, then led by one of Mr. Reid's former aides, claimed that it lacked enough money to continue evaluating a licensing application for the site, including its overall safety, that had been submitted by the Department of Energy.
In the original licensing application for the prototype fast-breeder reactor, MONJU, the event progression during an unprotected loss of flow (ULOF), which is one of the technically inconceivable events postulated beyond design basis, was evaluated.
While the issues discussed here can have a significant influence on design certification or combined license applications for future reactors, they can also have secondary impacts on currently operating reactors.
Along with marketing partner Electricité de France, the utility, Areva is working furiously to submit license applications for a couple of reactors that would be built on sites that already have nuclear plants–one in Calvert Cliffs, Maryland, the other at Nine Mile Point, near Oswego, New York.
The MHRA said it would "continue to encourage companies to voluntarily submit medicines license applications for e-cigarettes and other nicotine containing products as medicines" and hoped to see more e-cigarettes and next generation nicotine delivery products submit applications in future.
Since up to 50,000 NHPs were already being sold in Canada when the regulations became law on January 1 , 2004 Health Canada has provided a six year transition period during which companies must submit product license applications for all existing products.
Though small game licenses aren't usually as regulated, many states only grant a specific number of certain license types each year, so you may want to pay attention to the date your state begins accepting license applications for the year.
"The company believes that its disclosures about the B.L.A. are accurate," he said, referring to its biologics license application for approval of Hemopure.
The messages, whose recipients were not disclosed, came to light recently when contractors working for the department were preparing to submit a license application for the project, at Yucca Mountain, 100 miles northwest of Las Vegas.
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