Apr 294 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 193 mineCTD Guidance Updates – What’s New in 2020FDA has released several updates to eCTD Guidances
Jan 235 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 ap...
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 the...
Oct 24, 20193 minDrug Master Files: Highlights of the Updated FDA GuidanceOn October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for Ind...
Oct 3, 20192 minNew Draft FDA Guidance: Electronic Format for Medical Device SubmissionsOn September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in Ele...
Sep 6, 20194 minFDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval ProductsBackground on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an a...
Jul 31, 20192 minFDA Ad-Promo Series: The Guidance Has Been Finalized – What’s Next For Sponsors?On June 21, 2019, FDA released the Finalized Guidance for Promotional Labeling and Advertising Materials for Human Prescription Drugs. Th...
