News Archiv

FDA updates Study Data Specification

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...[more]

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

The U.S. Food and Drug Administration has released a new draft guidance "PET Drug Applications — Content and Format for NDAs and ANDAs" intended to assist applicants in...[more]

US: FDA released Draft version 2.0 of eCTD validation criteria

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...[more]

Global: Controlled Vocabulary updated for RPS R2 DSTU by HL7

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

Updated information for RPS R2 DSTU released by HL7

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

Updated information regarding RPS R2 DSTU and RPS R3 available from HL7

Health Level 7 international has released new information regarding the development of the Regulated Product Submissions (RPS) standard.

The new information includes:

A new...[more]

New list of controlled vocabulary for RPS R2 DSTU available

A new list of controlled vocabulary for the Regulated Product Submission Release 2 - Draft Standard for Trial Use (RPS R2 DSTU) has been published on the RPS website of the HL7...[more]