Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device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

摘要

The Food and Drug Administration (FDA or agency) is announcing the availability of a draft guidance for industry entitled "Guidance for Sponsors, Industry, Researchers, Investigators, and FDA Staff: Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act (PHS Act), Added By Title VIII of The Food and Drug Administration Amendments Act of 2007." The draft guidance provides sponsors, industry, researchers, investigators, and FDA staff with the agency's views on some types of information and documents submitted to FDA that typically need not be accompanied by the certification described in section 402(j)(5)(B) of the PHS Act.