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Recent Blogs

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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Reg Ops Radar: eCTD & Regulatory Updates
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.

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