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Zdrowie i gospodarka · 27.01.1999

Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry: Designation, Development, and Application Review for Products in Fast-track Drug Development Programs

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information concerning submissions by sponsors of investigational new drugs and applicants for new drug approvals or biological licenses that request fast-track designation and the guidance for industry on fast- track drug development programs.

Source: Federal Register — Food and Drug AdministrationOpen original release →