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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.
June 14, 2021
The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.
June 11, 2021
As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.
The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.
Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.
June 10, 2021
FDA’s approval of Biogen’s treatment for Alzheimer’s disease has raised questions about the agency’s accelerated approval process.
June 08, 2021
An ANDA from Sandoz for albuterol sulfate inhalation aerosol was approved by FDA.
The vaccine is now authorized for ages 12 and older in European Union member states and the UK.
The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.
FDA has granted fast track designation to a GLP-1/glucagon dual agonist in development by Boehringer Ingelheim and Zealand Pharma for the treatment of NASH.
FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of plasminogen deficiency type 1.