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LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication
LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication

LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication. The collaboration pairs Reed Tech SingleSource™ for Medical Devices, which provides UDI regulatory data management technology, with 1WorldSync’s Global Data Synchronization Network (GDSN) capabilities. This allows MedTech companies to centrally manage and share product data required by global health authorities, customers, and stakeholders. The alliance assists the medical device industry in providing product information to regulatory systems, retailers, healthcare providers, and consumers, offering a comprehensive product data solution.

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FDA Issued Final Guidance on Over-the-Counter Monograph Submissions in Electronic Format
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.

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