Federal Register Notice: FDA is making available a guidance for industry entitled, Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007. The guidance reveals the agency's current thinking on types of applications and submissions that sponsors, industry, researchers, and investigators submit to FDA and accompanying certifications as described in Title VIII of the FDAAA. Title VIII added new provisions that require that additional information be submitted to the clinical trials data bank including expanded information on clinical trials and information on the results of clinical trials. To download this guidance, click here. To view this notice, click here.