The U.S. FDA has published numerous resources that teams can access to understand the requirements for a submission in electronic Common...

Introduction In 2015, the concept of grouped submissions was introduced with the implementation of the US Module 1 specification v3.3....

The FDA ad promo guidance, Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and...

O March 1, 2022, the US FDA will no longer be accepting the eCTD Module 1 specification v1.3 (US regional DTD v2.01)

Introduction If you have submitted an initial marketing application in the US over the past few years, you may have included a BIMO data...

WAYS describes the documentation required for 2253 submissions in eCTD format

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

FDA has released several updates to eCTD Guidances

Introduction The US NDA and EU MAA applications are complex projects that take careful strategic planning and time management. The two...

Every year, from October 1st to December 31st , sponsors are required to renew their Establishment Registrations with FDA, as well as...

On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...

On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...

Background on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an...

On June 21, 2019, FDA released the Finalized Guidance for Promotional Labeling and Advertising Materials for Human Prescription Drugs....