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Compiling US Orphan Drug Designation Requests

eCTD Guidance Updates – What’s New in 2020

Simultaneous US/EU Submissions: 5 Tips for Success

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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Annual Registration Renewals: Ensuring Compliance to Avoid Inactivation

Nov 4, 2019
6 min

Annual Registration Renewals: Ensuring Compliance to Avoid Inactivation

Every year, from October 1st to December 31st , sponsors are required to renew their Establishment Registrations with FDA, as well as their Drug Product Listings. Earlier this year, FDA announced a major “clean up” effort, warning sponsors that Drug Product Listings will be periodically inactivated if they fail to meet necessary registration renewal requirements. As we are currently in the reporting period for 2019, we will use this article to give a quick refresh on these tw

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Drug Master Files: Highlights of the Updated FDA Guidance

Oct 24, 2019
3 min

Drug Master Files: Highlights of the Updated FDA Guidance

On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for Industry”. This is the first formal to revision to this guidance that was originally published in September of 1989. Drug Master Files are a submission pathway for a sponsor to allow others to reference data related to facilities, processes, or articles used in the manufacturing, packaging, or storage of human drug products, while keeping the i

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New Draft FDA Guidance: Electronic Format for Medical Device Submissions

Oct 3, 2019
2 min

New Draft FDA Guidance: Electronic Format for Medical Device Submissions

On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.” This guidance was published in order to be compliant with the provision set in FDA Reauthorization Act of 2017, which amended the FD&C Act to clarify that any medical devices under 510(k), 513(f)(2)(A), 515(c), 515(d), 20 515(f), 520(g), 520(m),

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FDA Ad-Promo Series: Navigating eCTD Submissions for Accelerated Approval Products

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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FDA Ad-Promo Series: The Guidance Has Been Finalized – What’s Next For Sponsors?

Jul 31, 2019
2 min

FDA 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. The Original draft guidance was published in April of 2015. Below are a few key takeaways on the immediate transition activities: https://www.fda.gov/media/128163/download With the finalization of this guidance, after 24 months, Ad Promo submissions that fall under Section 745A(a) of the FD&C Act are required, by law, to be submitted in eCTD f

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