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A network of regulatory innovations to improve FDA quality assessments of human drug applications.
Tran, Russie; Fraser, Grace; Fisher, Adam C; Lee, Sau L; Boam, Ashley; Tsinontides, Stelios; Maguire, Jennifer; Yu, Lawrence X; Rosencrance, Susan; Kozlowski, Steven; Henry, Don.
Afiliación
  • Tran R; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Fraser G; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Fisher AC; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Lee SL; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Boam A; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Tsinontides S; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Maguire J; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Yu LX; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Rosencrance S; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Kozlowski S; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
  • Henry D; Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD 20993, United States of America.
Int J Pharm X ; 7: 100239, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38545329
ABSTRACT
A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA's Center for Drug Evaluation and Research (CDER) aims to enhance the quality assessment of submissions for new drugs, generic drugs, and biological products including biosimilars. These regulatory innovations include developing or contributing (i) the Knowledge-Aided Assessment and Structured Application (KASA), (ii) a new common technical document for quality (ICH M4Q(R2)), (iii) structured data on Pharmaceutical Quality/Chemistry, Manufacturing and Controls (PQ/CMC), (iv) Integrated Quality Assessment (IQA), (v) the Quality Surveillance Dashboard (QSD), and (vi) the Established Conditions tool from the ICH Q12 guideline. The innovations collectively drive CDER toward a more coordinated, effective, and efficient quality assessment. Improvements are made possible by structured regulatory submissions, a systems approach to quality risk management, and data-driven decisions based on science, risk, and effective knowledge management. The intended result is better availability of quality medicines for U.S. patients.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Int J Pharm X Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Int J Pharm X Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Países Bajos