A
Aaria
Is anyone aware of a matrix comparing US/FDA drugs regulations against US/FDA device regulations?
Please comment: is it required for a drug company to have a "quality manual?" This is standard practice in the device world but I cannot find any references to a requirement or suggestion to have one for drugs
Please comment: is it required for a drug company to have a "quality manual?" This is standard practice in the device world but I cannot find any references to a requirement or suggestion to have one for drugs