here is a link about this manufacturing requirement, but it doesn't specifically say 3 batches - maybe because I was wrong about that number. Not sure.: http://walkerbioscience.com/courses/bio37/FDA.pdf
here is a link about this manufacturing requirement, but it doesn't specifically say 3 batches - maybe because I was wrong about that number. Not sure.: http://walkerbioscience.com/courses/bio37/FDA.pdf