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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.
Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.
Safeguarding against microbial contamination requires rapid detection and innovative technology.
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
FDA can better monitor quality production of domestic versus foreign firms.
It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.
Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.