Quality/GMPs

July 01, 2020

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

July 01, 2020

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.

July 01, 2020

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

July 01, 2020

Safeguarding against microbial contamination requires rapid detection and innovative technology.

July 01, 2020

Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.

July 01, 2020

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

July 01, 2020

Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.

July 01, 2020

FDA can better monitor quality production of domestic versus foreign firms.

July 01, 2020

It is important to consider the feasibility, benefits, and limitations of each type of audit in advance.

July 01, 2020

Investigating the root causes of OOS conditions, product defects, and batch failures requires a systematic, thorough approach.