Comments Sought on Drug CMC Date Elements

Federal Register notice: FDA is requesting comment on draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for electronic submission. Standardized data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format. As a result, the established data elements and terminologies are intended to improve the efficiency and quality of the drug review process. The agency is seeking comment on the accuracy, suitability, and appropriateness of these data elements and terminologies for submitting PQ/CMC data. FDA is also considering implementing PQ/CMC requirements as a Health Level 7 (HL7) Structured Product Labeling document. The proposed data elements and terminologies can be obtained at https://www.regulations.gov in Docket No. FDA–2017–N–2166. To view the notice, click here.