FDA public meeting to discuss Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC)

Standardized Data for PQ/CMC Public Meeting Registration, Fri, Oct 19, 2018 at 9:00 AM | Eventbrite

The Food and Drug Administration (FDA or the Agency) is announcing the following public meeting entitled “Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC).” This public meeting is intended to provide members of the pharmaceutical industry and other interested stakeholders an opportunity to discuss with FDA, and provide input on, topics and issues related to standardized data for electronic submission of PQ/CMC data, as detailed in the 2017 Federal Register notice (FRN), “Draft Standardization of Pharmaceutical Quality/Chemistry Manufacturing and Control Data Elements and Terminologies.” FDA will use the information from the public meeting to improve the usability of the proposed data standards. The public meeting will be held on October 19, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments on this public meeting by November 16, 2018. Registration and additional information is available HERE.