Apr 29, 20204 minCompiling US Orphan Drug Designation RequestsIn the United States, the Orphan Drug Act (ODA) was passed in 1983 to facilitate the development of drugs or biologics that are used for the
Mar 19, 20203 mineCTD Guidance Updates – What’s New in 2020FDA has released several updates to eCTD Guidances
Jan 23, 20205 minSimultaneous US/EU Submissions: 5 Tips for SuccessIntroduction The US NDA and EU MAA applications are complex projects that take careful strategic planning and time management. The two...
Nov 4, 20196 minAnnual Registration Renewals: Ensuring Compliance to Avoid InactivationEvery year, from October 1st to December 31st , sponsors are required to renew their Establishment Registrations with FDA, as well as...