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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.
February 01, 2023
FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.
FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
January 31, 2023
FDA will restart in-person, face-to-face meetings with industry sponsors beginning Feb. 13, 2023, after a shift to all-virtual meetings during the pandemic.
January 30, 2023
FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.
January 23, 2023
In a response letter, FDA stated that it could not grant Eli Lilly and Company accelerated approval due to concerns surrounding insufficient quantity of clinical trial data.
January 13, 2023
The Vault Quality Suite will help Adare simplify its quality operations across its sites in the United States, France, and Italy.
January 11, 2023
The company was awarded the Terra Carta Seal in recognition of its commitment to creating a sustainable future.
January 10, 2023
Eisai’s Alzheimer’s treatment, Leqembi (lecanemab-irmb), received approval from FDA via the Accelerated Approval pathway.
January 05, 2023
The agency revised a regulation to enable pharmacies to dispense mifepristone directly to individuals with a prescription.
January 03, 2023
Bio/pharma has evolved and adapted to a variety of challenges in 2022, but what might be on the cards for the industry in 2023?