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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
January 28, 2020
The agency has published seven guidance documents directed at the development and manufacture of gene therapies.
January 27, 2020
The agency celebrates the efforts it has made in creating a system for the evaluation and supervision of medicines throughout the European Union.
January 22, 2020
FDA revised the guidance after industry feedback and to clarify CGMP requirements for outsourcing facility operations.
January 21, 2020
The agency’s joint Big Data Task Force and the Heads of Medicines Agencies proposed actions for the use of big data to support innovation and public health.
January 17, 2020
FDA sent a warning letter to Health Pharma USA after an inspection found the company’s quality unit was not properly overseeing its drug manufacturing operations.
January 16, 2020
FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.
January 15, 2020
Tracking and implementing label changes are crucial to the lifecycle of a marketed drug product.
January 14, 2020
Top of CDER’s to-do list for 2020 is tracking adverse events more effectively and combating the opioid crisis.
January 09, 2020
The company has various projects and launches scheduled for 2020 as part of its anniversary celebration.
January 03, 2020
The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.