OR WAIT null SECS
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 24, 2023
The framework is now expanded beyond COVID-19 vaccines and treatments.
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.
July 20, 2023
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
The new drug may help vulnerable children resist RSV in the coming fall and winter season.
July 13, 2023
Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.
Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.
The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.
July 11, 2023
FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition
July 06, 2023
EMA, the European Commission, and HMAs are phasing out the flexible regulations put into place during the pandemic.