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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.
March 15, 2023
A phase-appropriate analytical development strategy is crucial, especially for complex (formulated) drug substances.
The impact of the potential ban would have serious consequences for the availability of many drugs for European patients.
Manual aseptic operations make quality practices necessary in the manufacturing of compounded drugs.
By leveraging certain strategies, organizations can effectively close data gaps and achieve more accurate and effective machine learning models in pharmacovigilance.
Quality quartets support an integrated and stable combination of commissioning and qualification and quality risk management processes.
March 14, 2023
FDA has approved Acadia Pharmaceuticlas’ Daybue (trofinetide), the first treatment for Rett syndrome, a rare genetic disorder.
FDA has approved Pfizer’s ZAVZPRET (zavegepant), a new nasal spray treatment for migraine.
FDA is seeking $7.2 billion to enhance food safety and advance medical product availability.
March 10, 2023
Even after an FDA advisory panel voted 14–1 in October 2022 to remove the drug, Makena manufacturer Covis Pharma continued to press for some continued access to the therapy.
March 09, 2023
Congressional leaders are investigating how pharmacy benefit managers determine health plan coverage and charges for medicines.