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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 27, 2021
Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.
FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).
FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.
The European Commission has approved UCB's treatment for adults with moderate-to-severe plaque psoriasis, BIMZELX (bimekizumab).
August 26, 2021
MHRA has approved Scancell’s clinical trial application for the initiation of the first-in-human Phase I/II study of Modi-1—a therapeutic vaccine candidate from the company's Moditope platform.
August 24, 2021
FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.
FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.
FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.
August 20, 2021
MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.
Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.