The FDA advisory committee hearing last Thursday for the Augment PMA, filed by BioMimetic Therapeutics (Franklin, Tennessee), went fairly well considering all the doom-and-gloom that preceded the event, but the hearing was conspicuous on at least one account. FDA's questions to the advisory committee's panelists covered the garden-variety questions seen in such meetings, but the agency also asked the panel whether the application needed more data on toxicology and teratogenicity (fetal effects) before the product goes to market. (Medical Device Daily) Read More
