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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.
August 02, 2023
Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.
The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.
An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.
Environmental monitoring data can help keep sterile environments sterile.
August 01, 2023
The program aims to aid submissions from external stakeholders and FDA staff.
The guidance document outlines recommendations to limit potential carcinogenic risk.
In this episode, David Tisi and Reenal Gandhi provide expert insights into advances and innovations changing the drug dosage form landscape.
July 28, 2023
Pandemic, PBM, and other policies on hold during the summer recess.
July 27, 2023
Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.
July 25, 2023
The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.