News Archive

FDA releases draft Module 1 specification v2.0 - not for implementation

27.10.2011
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The U.S. Food and Drug Administration (FDA) has published the draft "eCTD Backbone Files Specification for Module 1 Version 2.0" together with the updated...[mehr]

PDUFA V draft performance goals and procedures foresee mandatory eCTD submissions for human medicinal products in U.S.

07.09.2011
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The U.S. Food and Drug Administration (FDA) has published the draft PDUFA V (Prescription Drug User Fee Act) "Reauthorization Performances Goals and Procedures Fiscal Years...[mehr]

FDA updates Study Data Specification

06.07.2011

The U.S. Food and Drug Administration (FDA) has released an updated version 1.6 of the "Study Data Specifications" used for submitting animal and human study datasets in...[mehr]

FDA releases guidance for content and format for NDAs and ANDAs of PET applications

07.02.2011
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The U.S. Food and Drug Administration has released a new draft guidance "PET Drug Applications — Content and Format for NDAs and ANDAs" intended to assist applicants in...[mehr]

US: FDA released Draft version 2.0 of eCTD validation criteria

10.12.2010
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The US Food and Drug Administration has released a Draft version 2.0 of the "Specifications for eCTD Validation Criteria". The specifications are detailing the...[mehr]

Global: Controlled Vocabulary updated for RPS R2 DSTU by HL7

11.10.2010

Health Level 7 international (HL7) has released an updated version of the controlled vocabulary for the "next-generation" electronic submission standard RPS (Regulated...[mehr]

Updated information for RPS R2 DSTU released by HL7

23.09.2010

Health Level 7 international (HL7) has released updated information regarding the development of the Regulated Product Submissions (RPS) standard. The information concerns the...[mehr]

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