Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products." This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biosimilar products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This draft guidance for industry revises and replaces the draft guidance of the same name issued in June 2018.