During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market...
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Pharmaceutical and Cosmetics
Recent Blogs
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.
Takeaways from 2024 IBA Cosmetics Convergence
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.
Expert Insights on the EU Proposed Legislation EUDAMED Rollout-Approved
On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
FDA Plans for Artificial Intelligence and Medical Products
AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.
MoCRA’s Impact on Private Label Cosmetic Manufacturers: Navigating the New Era of Beauty Compliance
The Modernization of Cosmetics Regulation Act (MoCRA) is here, and it’s about to shake up the industry. As the FDA gears up to implement MoCRA by July 2024, it’s time for private label manufacturers to get their ducks in a row and embrace the new era of beauty compliance.
FDA Releases Drug Amount Report Final Guidance and Updated Deadlines
After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting...
2024 MoCRA Update: Delays, Enforcement and More
As the first US cosmetic regulation in over 80 years is finally being implemented, Reed Tech is keep a close eye on...
MoCRA Submission Encouraged by Dec. 29, 2023; Enforcement Delayed
On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline.