Zdrowie i gospodarka · 21.10.1998
Agency Emergency Processing Request Under OMB Review
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the submission by sponsors of investigational new drugs and applicants for new drug approvals or biological licenses under the Federal Food, Drug, and Cosmetic Act (the act) and the guidance for industry on fast track drug development programs.