Memo To File: How US FDA Decided Which Janssen Vaccine Drug Substance Batches Were OK To Use
Two batches were authorized because they were made before production waste jammed Emergent BioSolutions' Bayview plant.
You may also be interested in...
US FDA oversees plants straining to meet demand for COVID-19 vaccines and treatments, while cracking down on adulterated hand sanitizers.
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.
After discovery of viral vector cross-contamination, AstraZeneca quit, J&J took control and the FDA launched inspection.