FDA Form 3439, Interim Form for Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of FDA Form 3439 entitled, ``Application to Market a New Drug, Biologic, or Antibiotic Drug for Human Use.'' This form is intended for use by applicants for licenses for specified biotechnology and specified synthetic biological products. FDA Form 3439 has received interim approval from the Office of Management and Budget (OMB) for use by applicants pending the availability of a harmonized form for use by applicants requesting approval of drugs, biological products, and antibiotics. The development of the harmonized form and this action are part of FDA's continuing effort to achieve the objectives of the President's ``Reinventing Government'' initiatives.