Compiling US Orphan Drug Designation Requests
In 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
Compiling US Orphan Drug Designation Requests
eCTD Guidance Updates – What’s New in 2020
Simultaneous US/EU Submissions: 5 Tips for Success
Annual Registration Renewals: Ensuring Compliance to Avoid Inactivation
Drug Master Files: Highlights of the Updated FDA Guidance
New Draft FDA Guidance: Electronic Format for Medical Device Submissions
FDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval Products
FDA Ad-Promo Series: The Guidance Has Been Finalized – What’s Next For Sponsors?