Your Article Summary
BioMimetic Therapeutics Submits First Two PMA Modules to FDA; Company Receives ISO 9001 Certification and ISO 13485 Recertification
BioMimetic Therapeutics, 06/18/09
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.
Today in Drug/Product Approvals...keeping you current
Receive free subspecialty "5-minute updates" via email
FDA Approves Gardasil to Prevent Genital Warts in Males. Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
American Family Physician, 10/27/09
Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Novartis, 09/18/09
Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/09/09
Article Search
Sponsor


See Latest Articles


