FDA Wants More Analysis From BioMimetic On Augment Bone Graft
Agency issues “not approvable” letter seeking more detailed analysis from the firm’s already-completed pivotal trial, but FDA is not asking for a new clinical study, BioMimetic stressed.
Agency issues “not approvable” letter seeking more detailed analysis from the firm’s already-completed pivotal trial, but FDA is not asking for a new clinical study, BioMimetic stressed.