Blog | WAYS Pharmaceutical Services

Apr 6
5 min

The Basics of BIMO

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

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Jul 22, 2020
3 min

FDA Ad-Promo Series: 2253 Submissions in eCTD Format

WAYS describes the documentation required for 2253 submissions in eCTD format

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Apr 29, 2020
4 min

Compiling US Orphan Drug Designation Requests

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

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Mar 19, 2020
3 min

eCTD Guidance Updates – What’s New in 2020

FDA has released several updates to eCTD Guidances

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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...

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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...

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On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...

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On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...

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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...

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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....

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