Failed bioequivalence submissions
FDA proposes amending its ANDA in vivo bioequivalence regulations to require submission of data "from all BE studies the applicant conducts on a drug product formulation submitted for approval," instead of only those studies meeting the necessary BE criteria. The amended regs will require "all additional passing and nonpassing BE studies conducted" to be submitted "in either a complete or summary report," HHS' Unified Agenda for 2002 says. The advance notice of proposed rulemaking is due out in February. FDA is concerned that submissions often do not include failed BE studies (1"The Pink Sheet" Oct. 23, 2000, p. 25)...
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A proposed rule to require ANDA sponsors to submit all bioequivalence studies they complete would increase annual BE study reports by 10%, FDA estimates
FDA is considering issuing a guidance with instructions for ANDA sponsors on submitting failed bioequivalence studies.
With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?