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 application types share many common elements: once one is completed, it can be repurposed to create the other. However, it is a unique challenge to build and submit both applications in the same time frame. The WAYS staff has vast experience in working within very demanding timelines and have developed 5 key tips in balancing the simultaneous

Background on Subpart H/E Products For life-threatening diseases where there is no current marketed treatment, the FDA may allow for an accelerated approval under section 233 506(c) of the FD&C Act, 21 CFR 314 (subpart H) for drugs, and 21 CFR 601 (subpart E) for biologics. In these cases, the approval could potentially be granted based on early Phase I/II clinical data. Products falling under subpart H/E are required to have all Advertising and Promotional items reviewed by