FDA Requesting Comments on the draft Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies

Of interest to those working in the PQ OR CMC spaces and wanting to keep abreast of the latest in FDA thinking, the FDA is requesting comments on the draft "Pharmaceutical Quality/Chemistry Manufacturing and Controls (PQ/CMC) Data Elements and Terminologies" document.  These data elements and terminologies are used in electronic submissions of PQ/CMC data within filings. "... the Agency is continuing to seek comment on the accuracy, suitability, and appropriateness of revised and/or new data elements and terminologies for submission of PQ/CMC data."

 Extensive details on the Background and the Establishment of a Docket are available at the provided link.