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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
Apr 29, 20204 min read
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eCTD Guidance Updates – What’s New in 2020
FDA has released several updates to eCTD Guidances
Mar 19, 20203 min read
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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...
Jan 23, 20205 min read
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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...
Nov 4, 20196 min read
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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On October 18, 2019, FDA released an updated draft Guidance regarding Drug Master Files (DMFs) titled “Drug Master Files Guidance for...
Oct 24, 20193 min read
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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On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in...
Oct 3, 20192 min read
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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...
Sep 6, 20194 min read
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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....
Jul 31, 20192 min read
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