HeartWare said that the FDA was requiring the company to perform a post-approval study in the form of a registry consisting of 600 HeartWare patients and an additional 600 control patients.
Some panel members said they felt more needed to be done before approval because when the FDA requires a drug company to do a big, post-approval trial, it often gets done slowly or not at all.
Study after respected study has said that the FDA office responsible for post-market review of drug safety ought to have equal footing with the FDA's drug approval office.