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Webinar Recap | CARES Act Reporting: Strategies for Efficient Submissions
Webinar Recap | CARES Act Reporting: Strategies for Efficient Submissions

As most drug companies are aware of at this point, the CARES Act requires drug manufacturers to report annual production amounts to the FDA. This requirement has been rolling out over the course of 2024 and, here at LexisNexis Reed Tech, we are receiving many questions from our customers have had questions about how to meet these requirements.

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Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS
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.

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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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July 31st Deadline Approaching for CARES Act Report
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.

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