FDA Issues Draft Guidance for Industry: Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products – Drug Information Update

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or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 biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).  The previous guidance for industry entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants,” issued on November 18, 2015, has been withdrawn.      

Today’s updated draft guidance on formal meetings between FDA and biosimilar sponsors is another step we’re taking to assist applicants in their development of low-cost biosimilar and interchangeable products.  For information on how to submit comments on the draft guidance, see the Federal Register notice.