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November 03, 2023
Dujuan Lu, PhD, global leader—E&L, SGS Health Sciences, recommends some key issues that pharma manufacturers should consider when formulating products that require a medical device.
November 02, 2023
More attention should be given to how expert opinions and judgments are elicited for reducing uncertainty in quality risk management and risk-based decision making.
October 18, 2023
Companies can benefit from developing a single programmatic approach to a GxP training matrix.
October 12, 2023
The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.
October 11, 2023
Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).
October 05, 2023
The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.
September 29, 2023
A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.
September 26, 2023
The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.
September 20, 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.