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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.
October 13, 2022
FDA amended its authorization for the Moderna and Pfizer-BioNTech bivalent booster vaccines to permit their use in children as young as five years old.
October 12, 2022
CBER maps modernization plan to handle surge in research and applications.
October 06, 2022
The UK’s MHRA has approved Colonis’ melatonin oral solution for sleep onset insomnia in children and adolescents with ADHD.
October 05, 2022
Production of viral vectors requires a holistic view of the product, including its manufacturing process and its ultimate end use.
October 04, 2022
FDA has granted Fast Track designation for CUE-101, a treatment of recurrent/metastatic head and neck squamous cell carcinoma.
October 03, 2022
This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.
October 02, 2022
Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.
Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.
FDA backs joint reviews, common research policies, and modern production methods around the world.