BioMimetic Therapeutics Submits First Two PMA Modules to FDA; Company Receives ISO 9001 Certification and ISO 13485 Recertification BioMimetic Therapeutics, Inc. announced it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data, in the fourth quarter of 2009. [more...]
