Pharmaceutical and Cosmetics Archives

Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know

Drug Label Research, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

Navigating drug and device regulations isn’t optional—it’s mission-critical. This Regulatory Survival Guide breaks down the complexities of global compliance, from FDA and EU MDR to Health Canada, UDI, and MoCRA. Whether you’re managing submissions or facing upcoming deadlines, use this FAQ to decode key terms, avoid costly risks, and stay ahead with expert-backed solutions like Compliance-as-a-Service (CaaS).

Reflecting on RAPS Euro Convergence 2025: Regulatory Innovation in Motion

Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.

Shifting Manufacturing? Don’t Let Tariffs Disrupt Your Labeling Compliance

Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.

ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know

Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.

Health Canada’s Progress on Implementing the XML Product Monograph Requirement

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

Health Canada continues to make strides in modernizing the way pharmaceutical product information is structured and shared. As part of its digital transformation efforts, the agency is advancing the implementation of the XML Product Monograph (XML-PM) requirement, which is set to enhance efficiency, accessibility, and interoperability of drug labeling information across the industry.

Missed FDA Annual Deadlines? It’s not too late to correct your listings!

Drug & Biologic Product Submissions, Pharmaceutical and Cosmetics

The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year. Most of...

FDA to Revoke Authorization for Red No. 3 in Food and Drugs

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

FDA is taking a decisive step to revoke the authorization for the use of Food, Drug & Cosmetic Red No. 3 in food and ingested drugs.

Webinar Recap | Comply with Pharma Year-End Deadlines: 2024 Mandate Update

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

This webinar provides a comprehensive overview of pharma year-end reporting obligations, including blanket no-change certification options and new OTC Monograph mandates, the timelines for reporting and the process for submitting reports to the FDA.

Health Canada Announces Mandatory Use of XML Product Monograph in 2025

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

Health Canada is introducing the mandatory use of the extensible markup language product monograph (XML PM) in phases, with the first phase taking effect on July 18, 2025. This initial phase will require certain submission types to include the XML PM at the time of filing.

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