This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

FDA Drug Listing: When You Need a Manual Override


FDA Drug Listing: When You Need a Manual Override

|

Where am I - content-blog-article.php

One of the great things about the FDA’s electronic Drug Registration and Listing System (eDRLS) is the automatic data validation process. When you submit a Structured Product Labeling (SPL) file to the FDA over the Electronic Submissions Gateway (ESG), the contents are automatically checked against the SPL schema and FDA business rules. If a file […]

The Continuing Evolution of UDI: Highlights from the 2018 UDI Conference (Part 2 of 2)

|

Where am I - content-blog-article.php

Please note, this is Part Two of a two-part blog on the 2018 UDI Conference. You can read Part One here. FDA Makes GUDID Changes to Improve Data Quality Throughout the UDI Conference, FDA representatives continued to drive home the message of their 2018 data quality campaign during multiple sessions. In particular, Indira Konduri of […]

UDI Flows Downstream: Highlights from the 2018 UDI Conference (Part 1 of 2)

|

Where am I - content-blog-article.php

 At the end of April, medical device regulatory professionals, FDA representatives, technology providers and other industry members met together in Baltimore to discuss all things related to Unique Device Identification at the annual UDI Conference. If there was one overarching theme to the conference presentations and conversations overheard in the exhibit hall, at the lunch […]

FDA is Sharpening its Focus on UDI Data Quality

|

Where am I - content-blog-article.php

In recent months, the Food and Drug Administration has continued to build on its message of the importance of data quality in its Unique Device Identification database, the GUDID. In a recent presentation to the Dental Trade Alliance, FDA GUDID Program Manager Indira Konduri reminded medical device industry members to avoid common data quality errors […]