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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.
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.
FDA is taking a decisive step to revoke the authorization for the use of Food, Drug & Cosmetic Red No. 3 in food and ingested drugs.
The U.S. Food and Drug Administration (FDA) announced today, October 31, 2024, that it has approved a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS). This modification aims to provide patients and caregivers with a free, pre-paid drug mail-back envelope from outpatient pharmacies or other dispensers of opioid analgesics.
Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
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.
During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market for existing drug products for any number of reasons. These reasons can vary greatly depending on factors such as if the drug is Rx, OTC or biologic...
AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.
The Modernization of Cosmetics Regulation Act (MoCRA) is here, and it’s about to shake up the industry. As the FDA gears up to implement MoCRA by July 2024, it’s time for private label manufacturers to get their ducks in a row and embrace the new era of beauty compliance.
After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act – or as Reed Tech has taken to...