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Geschäft · 17.3.20141 Min. Lesezeit
New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information would be disclosed by the Agency. This change would ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It would also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →