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Recent Blogs

Webinar Recap | CARES Act Reporting: Strategies for Efficient Submissions
Webinar Recap | CARES Act Reporting: Strategies for Efficient Submissions

As most drug companies are aware of at this point, the CARES Act requires drug manufacturers to report annual production amounts to the FDA. This requirement has been rolling out over the course of 2024 and, here at LexisNexis Reed Tech, we are receiving many questions from our customers have had questions about how to meet these requirements. As such, we presented a webinar CARES Act Reporting: Strategies for Efficient Submissions covering the requirements, timelines and strategies for efficient reporting. The webinar was presented by LexisNexis Reed Tech subject-matter experts Gary Saner, Senior Regulatory Principal, Life Sciences.

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LexisNexis Reed Tech and 1WorldSync Webinar Recap: Leveraging UDI and GDSN
LexisNexis Reed Tech and 1WorldSync Webinar Recap: Leveraging UDI and GDSN

On Tuesday, October 15, 2024, Reed Tech and 1WorldSync hosted a highly informative webinar led by Gary Saner, Senior Regulatory Principal at Reed Tech, and Scott Brown, Senior Director of Global Data Strategy at 1WorldSync. The webinar focused on how their continued alliance helps companies navigate Unique Device Identification (UDI) management and utilize the Global Data Synchronization Network (GDSN) to meet regulatory compliance requirements.  

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Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS
Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) has introduced reforms to the OTC drug review process. Starting October 1, 2024, the listing of OTC monograph drug products will require the use of the current Marketing Category and Application Number values in the FDA’s Electronic Drug Registration and Listing System (eDRLS), and will not be able to be certified under the old marketing categories and old application number fields.

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