Breast implant guidance
This article was originally published in The Gray Sheet
Executive Summary
Comments on FDA's Jan. 8 draft guidance on saline, silicone and "alternative" breast implants are due to the agency by April 12. The guidance was released after FDA issued a "not approvable" letter for Inamed's silicone breast implant premarket application (1"The Gray Sheet" Jan. 12, 2003, p. 3)...