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- Jan 23, 2020
- 5 min
Simultaneous US/EU Submissions: 5 Tips for Success
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
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- Sep 6, 2019
- 4 min
FDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval Products
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
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