Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants

Streszczenie

The Food and Drug Administration (FDA) is announcing that a collection of information entitled "Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicant" has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.