Guidance for Industry on Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants

OMB 0910-0802

Latest Forms, Documents, and Supporting Material

Document Name
SUPPORTING STATEMENT FINAL FORMAL MEETINGS AND BBPS 6-24-2015.doc Supporting Statement A
Information Packages: CBER Other-Guidance
Information Packages: CDER Other-Guidance
Meeting Requests: CBER Other-Guidance
Meeting Request: CDER Other-Guidance