Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
Takeaways from RAPS Convergence 2024: Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
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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.
LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication
LexisNexis Reed Tech and 1WorldSync collaborate to provide medical device manufacturers with a comprehensive solution for managing regulatory UDI submissions and syndicating accurate product data globally.
Discontinuation and Relisting Features added to MoCRA
The U.S. Food and Drug Administration (FDA) has recently announced the release of two new features for cosmetic product registration and listing. These new Modernization of Cosmetics Reform Act of 2022 (MoCRA) features are designed to simplify the process of managing cosmetic product information for responsible persons.
FDA Issued Final Guidance on Over-the-Counter Monograph Submissions in Electronic Format
The FDA has issued the final guidance “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This new guidance mandates electronic submission of all Over-the-Counter (OTC) monograph materials, marking a significant shift in the regulatory landscape. By transitioning to electronic submissions, the FDA has expressed aim to streamline the review process, enhance transparency and facilitate faster decision-making for OTC drug approvals.
Takeaways from DIA Global Annual Meeting in San Diego
This past June, Reed Tech Life Sciences team members attended the 60th Anniversary of the DIA Global Annual Meeting in San Diego, California.
Reg Ops Radar: eCTD & Regulatory Updates
Industry is currently seeing rapid changes and improvements to existing eCTD formats, requirements and suggested uses from FDA. Here at LexisNexis Reed Tech, we want to be sure that our customers are not only up-to-date with, but understand, these new developments. To support this knowledge share, our in-house team of eCTD experts will be offering insights on a regular cadence this summer.
FDA Plans for Artificial Intelligence and Medical Products
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.
MoCRA’s Impact on Private Label Cosmetic Manufacturers: Navigating the New Era of Beauty Compliance
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.