Zdrowie i gospodarka · 02/10/1998

Draft Guidance for Industry on Submitting Debarment Certification Statements; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submitting Debarment Certification Statements.'' The draft guidance addresses the most commonly asked questions about debarment certification statements and information requirements under the Federal Food, Drug, and Cosmetic Act (the act) and is intended to assist in the submission of applications for human, animal, and biologic drug products, export applications for certain unapproved products, and supplements to certain drug product applications.