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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 13, 2020
The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.
July 09, 2020
FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.
July 02, 2020
It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.
FDA Commissioner Hahn commits to a science-based review and approval process.
483s and Warning Letters Point to Inadequate Quality Oversight
July 01, 2020
FDA can better monitor quality production of domestic versus foreign firms.
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.