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ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know
ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know

As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.

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Health Canada’s Progress on Implementing the XML Product Monograph Requirement
Health Canada’s Progress on Implementing the XML Product Monograph Requirement

Health Canada continues to make strides in modernizing the way pharmaceutical product information is structured and shared. As part of its digital transformation efforts, the agency is advancing the implementation of the XML Product Monograph (XML-PM) requirement, which is set to enhance efficiency, accessibility, and interoperability of drug labeling information across the industry.

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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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