DSCSA/ Electronic Study Data Standards/ Pediatric Safety Study Workshop

DSCSA/Electronic Study Data Standards/ Pediatric Safety Study Workshop

 1. Identifying Trading Partners Under the Drug Supply Chain Security Act - Draft Guidance:

The FDA is issuing this guidance to assist industry and State and local governments in understanding how to categorize the entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (DSCSA).  This guidance explains how to determine when certain statutory requirements will apply to entities that may be considered trading partners in the drug supply chain. FDA is also soliciting public input specific to the activities of ‘‘private-label distributors’’ of drug products and whether those activities fall within the definitions under DSCSA of the various trading partners.

2. Electronic Study Data Submission; Data Standards; Support for Standard for Exchange of Nonclinical Data Implementation Guide Version 3.1

FDA is announcing support for the 3.1 version of Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data (SEND IG 3.1), the end of support for the 3.0 version of SEND IG, and an update to the FDA Data Standards Catalog (Catalog). SEND IG 3.1 has been available from CDISCsince July 2016. FDA is encouraging sponsors and applicants to use SEND IG 3.1 in investigational study data provided in regulatory submissions to CDER.

3. Advancing the Development of Pediatric Therapeutics: Application of ‘‘Big Data’’ to Pediatric Safety Studies; Public Workshop

The Office of Pediatric Therapeutics, FDA, is announcing a public workshop entitled ‘‘Advancing the Development of Pediatric Therapeutics (ADEPT): Application of ‘‘Big Data’’ to Pediatric Safety Studies.’’ The purpose of this 2-day workshop is to understand how to access and analyze ‘‘Big Data’’ associated with safety information in the health care setting, and the utility and challenges associated with the use of ‘‘Big Data’’ to study the safety of therapeutics in children.

The public workshop will be held on September 18 and 19, 2017, from 8:30 a.m. to 5 p.m. at the DoubleTree by Hilton Hotel in Silver Spring, MD 20910. The workshop will also be webcast and registration is require