Pharmaceutical and Cosmetics Archives

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

Company News, Drug & Biologic Product Submissions, Medical Devices, Unique Device Identification

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

Life Sciences, Medical Devices, Pharmaceutical and Cosmetics

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

Life Sciences, Pharmaceutical and Cosmetics

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

Life Sciences, Pharmaceutical and Cosmetics

After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting...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

Life Sciences, Pharmaceutical and Cosmetics

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

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

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.

Health Canada Releases XML PM Draft Guidance

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files.

Revisions to FDA-Forms 365h and 1571

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

The US Food and Drug Administration (FDA) has recently made updates to forms 365h and 1571. Form 365h is “Application to Market a New or Abbreviated New Drug or Biologic for Human Use”. These applications are commonly referred to as NDA, ANDA or BLA. Form 1571 is “Investigational New Drug Application (IND)”. These are among the most important eCTD forms involved in your drug or biologic application process.

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