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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 02, 2021
Public health challenges have highlighted the need for agility in maintaining the quality of medicines.
A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing.
October 01, 2021
Appili Therapeutics and AiPharma Global Holdings announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form for the treatment of COVID-19.
FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.
EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax.
EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.
September 30, 2021
FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.
FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.
September 29, 2021
GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.