A recent Forbes article noted that the FDA will make an exception and forgo Covid-19 vaccine manufacturing plant inspections. According to the FDA Director of Viral Products, as candidates approach the final phase of testing, emergency use authorization will be granted without pre-approval inspections. Under normal circumstances, it is required that the FDA inspect several batches of vaccines to ensure they are made with the same safety, consistency, and potency standards.
PACK EXPO Connects Trend Chat
Serialization and the cold chain for new COVID-19 vaccines and treatments—and how food is starting to feel a lot more like pharma regarding regulatory hurdles. PACK EXPO Connects Trend Chat Wednesday, November 11 • 2:30 PM - 3:00 PM CT. More info here.