Revised Form FDA 356h, Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a revised Form FDA 356h entitled ``Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use.'' This revised form is intended to be used by applicants for a wide range of products regulated by the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) under the Public Health Service Act (the PHS Act) and the Federal Food, Drug, and Cosmetic Act (the act). The revised form is also intended to standardize the application form, to reduce the time required to prepare applications, and to expedite review by FDA staff. This action is part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives, and is intended to reduce unnecessary burdens for industry without diminishing public health protection.