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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 18, 2021
FDA approves Merck’s Welireg for the treatment of adult patients with von Hippel-Lindau disease who require therapy for tumor growth.
WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.
BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.
Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.
Cipla receives final approval from FDA for its abbreviated new drug application for difluprednate ophthalmic emulsion 0.05%.
August 17, 2021
FDA has granted its first approval for an idiopathic hypersomnia treatment.
August 16, 2021
FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.
August 13, 2021
The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.
The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.
August 12, 2021
The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.