Pharmaceutical and Cosmetics Archives

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

Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical and Cosmetics

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.

Discontinuation and Relisting Features added to MoCRA

Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical and Cosmetics

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

Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical and Cosmetics

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

Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical and Cosmetics

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

Life Sciences, Pharmaceutical and Cosmetics

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

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

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.

Shaping the Future of Biopharma: Key FDA Decisions & Their Impact on Industry Dynamics

Pharmaceutical and Cosmetics

The biopharma industry is poised for significant transformation in the coming years, with several critical FDA decisions expected in the near future. These decisions will not only impact individual companies and products but have far-reaching implications for the entire industry— shaping market dynamics, investment strategies and the trajectory of innovation. As industry leaders navigate this complex landscape, they must remain vigilant of FDA’s actions and adapt their strategies to capitalize on emerging opportunities while mitigating potential risks.

Market Research in Early-Stage Drug Concept and Discovery

Drug & Biologic Product Submissions, Drug Label Research, Pharmaceutical and Cosmetics

During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market...

Takeaways from 2024 IBA Cosmetics Convergence

Pharmaceutical and Cosmetics

LexisNexis Reed Tech was pleased to sponsor, present, and attend the recent IBA (International Beauty Association) Cosmetics Convergence Spring Symposium. In addition to having great conversations with our industry peers, we attended many educational sessions, especially those concerning the new MoCRA regulations, and are happy to share some highlights here. For more information about MoCRA requirements and deadlines, please contact [email protected]. To learn more about IBA and their upcoming events, please visit their website.

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