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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.
May 02, 2022
What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?
ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.
FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.
Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.
April 27, 2022
Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.
April 26, 2022
Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.
April 25, 2022
FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.
Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.
EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.
EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.