The Modernization of Cosmetics Regulation Act of 2022 overhauls existing regulations, mandating FDA-established Good Manufacturing Practices for cosmetics manufacturers.
MoCRA: The Future of Cosmetic Regulations
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New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format
As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates will be required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by FDA in late December 2020. This means that any current REMS registrations will not need to be submitted in SPL until they require updates. There are currently 62 active REMS—58 ETASU (Elements to Assure Safe Use) and 4 basic (non-ETASU.)
Combination Products: Regulatory Requirements and How To Comply
Continue to be at the forefront of regulatory chatter. Our customers, both primarily medical device and primarily pharmaceutical, are regularly coming to us with questions surrounding this topic. Reed Tech answers these questions here in this blog post
What’s Been Happening with Health Canada XML PM Mandates?
Reed Tech recently presented a webinar to update customers with the most recent information about XML product...
DIA Global Labeling Takeaways: Patient Materials and Health Literacy
Reed Tech habitually attends industry conferences and forums to share our expertise and gain knowledge from our...
LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies
Discover LexisNexis Reed Tech and Schlafender Hase’s alliance for streamlined life sciences data management and regulatory solutions.
FDA Drug Distribution Amounts Report: Frequently Asked Questions and More
Recently, Reed Tech subject-matter experts, Gary Saner and David Wilson, hosted a webinar to provided a recap of what this new deadline means for pharma companies and how to ensure compliance, as well as explained the implications of recent updates and the progress of the draft guidance.
Public Dashboard Now Available for REMS Data
A new public dashboard has been launched by the Food and Drug Administration (FDA) for public access to data for drugs...
Updated Deadline: FDA Announces New Annual Drug Distribution Reporting Requirement
The Food and Drug Administration (FDA) has informed industry that the February 15, 2022 date for submitting 2020 data per Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act, originally referred to as a deadline, will now be the recommended date.