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April 25, 2023
Published by Med Search on April 25, 2023
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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
Published by Med Search on April 25, 2023
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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
Published by Med Search on April 25, 2023
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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
Published by Med Search on April 25, 2023
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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
Published by Med Search on April 25, 2023
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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
Published by Med Search on April 24, 2023
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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
Published by Med Search on April 21, 2023
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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
Published by Med Search on April 21, 2023
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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
Published by Med Search on April 20, 2023
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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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