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17:57 Feb 14, 2006
English to Spanish translations [Non-PRO] Law/Patents - Medical: Pharmaceuticals
English term or phrase:Filing/File
Ver documento abajo. Tengo dudas de cómo se traduce file y filing en este contexto.
A Company “submits” an NDA to the FDA. “Filing” is when the FDA conducts a preliminary review of the NDA and finds that the application is sufficiently complete for them to commence a substantive review. By default, NDAs are considered “filed” 60 calendar days after submission, unless the FDA notifies the sponsor to the contrary.