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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.
July 12, 2017
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
A recent paper coauthored by FDA’s Lawrence Yu and Michael Kopcha describes how the industry might modernize drug manufacturing.
July 11, 2017
In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.
July 10, 2017
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.
After FDA found a “significant shift in the route of abuse,” Endo voluntarily removes OPANA ER from the market.
July 05, 2017
The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.
July 02, 2017
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.
Real-time alternatives to dissolution testing are required for continuous manufacturing to reach mainstream use.