Federal Register Notice: FDA is making available a guidance for industry entitled Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. It provides information on implementing the new section FDCA 505(o)(3) added by the FDA Amendments Act of 2007 to require certain postmarketing studies and clinical trials for prescription drugs approved under the FD&C Act and biological products approved under the Public Health Service Act. It also describes which types of postmarketing studies and clinical trials will be required and which types will be agreed-upon commitments because they do not meet the statutory criteria for required studies and trials. To download this guidance, click here. To view this notice, click here.