viernes, 21 de julio de 2017

Request for comment on PQ/CMC data standardization

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FDA is Requesting Comment on Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) Data Elements and Terminologies
FDA continues to work with industry to develop data standards to enable a consistent, systematic approach to the data submission and data management for regulatory submissions.  FDA has recently focused on developing a standard content structure for selected Pharmaceutical Quality/Chemistry, Manufacturing and Control (PQ/CMC) information found in the electronic Common Technical Document (eCTD) submissions. 

To standardize and structure the content that is submitted in Module 3 of the eCTD, the FDA has undertaken a project to examine the PQ/CMC elements of drug substance and drug product. This will facilitate review and evaluation of the product/application. 

On July 11, 2017, FDA published a Federal Register Notice (FRN) to request that all interested parties provide comments regarding the PQ/CMC data elements, their definitions and the terminology.   
FDA is seeking input on the content of the standardization effort as it relates to the data elements and terminologies. This is intended to eventually become guidance on how drug product and drug substance information is submitted electronically to the agency. The FRN is available on  Comments and questions should be sent to the docket (FDA-2017-N-2166) by September 11, 2017.

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