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Zdrowie i gospodarka · 22.08.2018

Standardized Data for Pharmaceutical Quality/Chemistry Manufacturing and Control; Public Meeting

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.

Source: Federal Register — Food and Drug AdministrationOpen original release →