January 7, 2013
Hello. Thanks for the many useful blogs over the last year.
Background: It has been awhile since I worked in the drug world and my company is increasing its activity with new drug products.
Questions:
(1) Is anyone aware of a matrix comparing US/FDA drugs regulations against US/FDA device regulations?
(2) Please comment: is it required for a drug comapny 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.
Thanks,
Frank Pokrop
CareFusion
San Diego, CA