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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.
July 01, 2020
Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.
The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
June 30, 2020
The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
June 26, 2020
FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.
June 23, 2020
Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.
The agency will be waiving fees for scientific advice for academia developing orphan drugs.
June 22, 2020
The guidance document provides recommendations for CGMP expectations to prevent contamination of drugs and exclude sick workers from participating in drug manufacturing.