FDA to host public workshop on complex generic drug products January 9, 2018

FDA to host public workshop on complex generic drug products January 9, 2018
New Insights for Product Development and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products – January 9, 2018, from 8:30 a.m. - 4:30 p.m.

This workshop aims to present the outcomes from research projects initiated under the GDUFA Regulatory Science Research Program, discuss how regulatory science initiatives have helped address regulatory science knowledge gaps by providing insights on factors that influence the performance of generic OINDPs, share the Agency’s experience on the utility of novel analytical tools and methods developed under the regulatory science initiative for generic OINDP product development and bioequivalence assessments; and obtain input from the public on what, when, where, and how analytical methods and procedures should be applied in the development and review of abbreviated new drug applications (ANDAs) for complex OINDPs.

The workshop will be held on FDA’s main campus in Silver Spring, Maryland and will be webcast for those who cannot attend in person. Further information will be posted to the meeting webpage as it becomes available.