Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 21.12.20061 Min. Lesezeit
Guidance for Industry and Food and Drug Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Procedures for Handling Post- Approval Studies Imposed by PMA Order." The guidance provides a standard format and content for submitting post-approval studies. The guidance is issued to help ensure that sponsors provide adequate information about the conduct of post-approval studies and that the Center for Devices and Radiological Health (CDRH) can properly track and evaluate post-approval studies.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →