Agency Information Collection Activities; Announcement of OMB Approval; New Drugs and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

摘要

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "New Drugs and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.