Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants." This guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance assists sponsors and applicants in generating and submitting meeting requests and the associated meeting packages to FDA for biosimilar biological products. This guidance finalizes the draft guidance issued on April 1, 2013.