April 25, 2023


The PQ/CMC Data exchange standard is intended to be developed as Health Level 7 (HL7) Fast Health Interoperable Resources (FHIR) representation. The project has been established with […]
April 25, 2023


In 2019, FDA attempted to map PQ/CMC data elements to IDMP standards as relevant and document some details to show the similarities and the differences between […]
April 25, 2023

PQ/CMC Terminology

Phase 1 controlled terminology has been registered in National Cancer Institute’s (NCI) Enterprise Vocabulary Service (EVS) – NCI Thesaurus (NCIt). New controlled terminologies and updates to […]
April 25, 2023

PQ/CMC Conceptual Model

The Phase 1 data elements and controlled terminology have been published in the 2017 FRN. This is a high-level conceptual model covering the phase 1 groups/domains. […]
April 25, 2023

PQ/CMC Data Standards Scope & Development

PQ/CMC structuring and standardization is intended to be accomplished in multiple phases. For the first phase, the Agency has focused on some of the sections of […]
April 24, 2023

Regulatory Education for Industry (REdI) Annual Conference 2023 – 06/05/2023

On This Page Date: June 5 – 9, 2023 Time: 8:40 AM – 4:30 PM ET Visit CDER Small Business and Industry Assistance Page Patrizia Cavazzoni […]
April 21, 2023

Import of Drugs for Potential COVID-19 Treatment

FDA is working to address the COVID-19 pandemic by facilitating imports of drugs to potentially treat COVID-19. FDA is also working to protect Americans by monitoring […]
April 21, 2023

Industry Resources

FDA provides information to assist industry in the development of generic drugs and submission of abbreviated new drug applications (ANDAs). This section includes links to summary […]
April 20, 2023

FDA and NIH/NCI Center for Cancer Research: Advancing Drug Development in Myelodysplastic Syndromes – 05/16/2023

On This Page Date: May 16 – 17, 2023 Day1: Tue, May 16 12:30 PM – 5:00 PM ET Day2: Wed, May 17 12:30 PM – […]
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