1. Filing Determination
The primary goals of the filing process are to: (1) determine whether the submitted application meets the regulatory requirements for filing; (2) define the scope of review activity needed; and (3) identify major elements of the application that may pose concerns during the review.
http://www.fda.gov/downloads/Drugs/.../Guidances/ucm079748.p...

The primary goals of the filing determination and review planning process are to determine whether the submitted application meets the regulatory requirements for filing, to define the scope of review activity needed, and to identify major elements of the application that may pose concerns during the review.
The outcome of this stage is either acceptance of filing, or a refusal to file if issues that are identified cannot be resolved with the sponsor.
http://www.marsdd.com/dms/entrepreneurtoolkit/Regulatory-PDF...

The first stage is the "Filing Determination & Review Planning Stage," where reviewers from the FDA determine if the BLA meets the minimum standards that the FDA has set for filing an BLA, the amount of review required for the specific needs of the BLA, and the primary areas of the BLA that reviewers must focus on. FDA officials convene to produce a timeline for the rest of the review process. This process can be considered a planning stage, where all BLAs that meet the FDA requirements advance to the next stage [19].
http://2012.igem.org/Team:Penn/Perceptions

RECHT [CdT] Vollständiger Eintrag
EN the first filing
DE die erste Anmeldung
:
RECHT [CdT] Vollständiger Eintrag
EN equivalence of Community filing with national filing
DE Wirkung einer nationalen Hinterlegung der Anmeldung
:
http://iate.europa.eu/iatediff/SearchByQuery.do?method=searc...

[...] Should it be necessary to make use of those rights, such filing will contribute to an easier determination of authorship, of ownership of rights and of date of creation.
agcunhaferreira.pt
Allgemeinen Prüfung Kultureller Tätigkeiten" einzureichen, was im Falle einer Berufung auf solche Rechte stets zu einer einfacheren Bestimmung der Urheberschaft, des Eigentumsrechtes und des Tags der Schaffung beiträgt.
agcunhaferreira.pt

[...] for solving the problem of cases of multiple national filings and the criteria to be applied for determining which of these cases should be covered by the "one-stop [...] europa.eu
- den Mechanismus zur Lösung des Problems mehrfacher nationaler Anmeldungen und die Kriterien zur Festlegung der Fälle, für die das in der Fusionskontrollverordnung [...] europa.eu
http://www.linguee.de/deutsch-englisch/search?source=auto&qu...

Leider keine direkte Übersetzung gefunden.