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Recent Blogs
UDI Implementation Tips and GDSN Data Management
Learn four strategies to simplify UDI and GSDN data management for medical device companies and ensure compliance
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.
July 31st Deadline Approaching for CARES Act Report
The FDA CARES Act requires drug manufacturers, repackers and relabelers to submit annual reports on drug production volumes. Here are the key points: Deadline: July 31, 2024, for the 2023 calendar year; Who Must Report: All FDA-registered facilities under section 510(j)(3) of the Federal Food, Drug & Cosmetic Act; What to Report: Annual production volumes for each listed drug.