Day: September 10, 2020

Since FDA effectively stopped auditing manufacturers six months ago due the pandemic, no company has been found to be non-compliant. Whether this means lax enforcement or more compliant manufacturing is open to debate. It should be noted that up until 10th March, FDA had conducted 231 inspections, and issued 7 Warning Letters in about 2 … Read more

This week CEOs of nine biotech companies publicly pledged that they will not file for FDA approval or emergency authorization for their Covid vaccines unless they meet FDA’s established standards but this pledge may be hard to hold in the current circumstances. It is an odd pledge as it states the obvious; companies do not … Read more