Sentences with phrase «several new drug application»
Not exact matches
The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the applicatDrug Application by the manufacturer of the drug, and FDA review and approval of the aApplication by the manufacturer of the drug, and FDA review and approval of the applicatdrug, and FDA review and approval of the applicationapplication.
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In connection with this goal, Vanda's management team has been working diligently over the past several months with the Food & Drug Administration («FDA») to reevaluate its response to Vanda's New Drug Application («NDA») for iloperidone for the treatment of schizophrenia.