The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)... requested: a€c Type A for stalled drug development programs (e.g., Clinical Hold Letter, Complete Response Letter)a€”to be held ... of meeting request letter Content of meeting request letter: a€c A draft list of specific critical questions, as comprehensive and ... The first key CMC discussions between the sponsor and the FDA is the pre-Investigational this might be their first exposure to the regulatory agency.


Title:The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Author: John Geigert
Publisher:Springer Science & Business Media - 2014-07-08
ISBN-13:

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