To align with PDUFA VII , BsUFA III, and GDUFA III requirements as well as make other improvements to data quality and ease of use, FDA has revised form 356h: Application to Market a New or Abbreviated New Drug or Biologic for Human Use and form 1571: Investigational New Drug Application (IND). Please contact druginfo@fda.hhs.gov or industry.biologics@fda.gov with any questions about form revisions. Use these new versions to ensure new PDUFA, BsUFA, and GDUFA program data are collected.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!