Zdrowie i gospodarka · 18/07/2002

FDA Seeks Public Comment on Proposed Information Collection for PDUFA Meetings

The Food and Drug Administration (FDA) is seeking public comment on a proposed information collection related to formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products, as outlined in the FDA's guidance. The agency must publish this notice in the Federal Register and allow 60 days for public comment in accordance with the Paperwork Reduction Act of 1995.