Drug Label Research
This page provides blogs, short videos and recordings focused on the trends for drug label research
Recent Blogs
FDA Final Rule: Preparing for the Transition to a 12-Digit NDC
The FDA’s final rule standardizes National Drug Codes into a uniform 12-digit format beginning March 7, 2033. Pharmaceutical manufacturers, distributors, and healthcare stakeholders must prepare systems, labeling, serialization, and supply chain integrations during the transition period through 2036 to ensure compliance and avoid disruption.
FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars
The FDA has finalized guidance on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars, clarifying expectations to ensure communications are accurate, truthful, and not misleading across all media.
Printed Drug Labeling Requirements Remain in Effect
Understand how the US government shutdown affects FDA operations and how LexisNexis supports healthcare readiness.
Pharmaceutical Industry Top Innovators
Explore the key Pharmaceutical Innovators revealed in the latest Innovation Momentum report and their impact on the industry.
FHIR and the Future of Labeling
Learn how manufacturers can adopt FHIR to modernize labeling, enhance traceability, and meet evolving regulatory expectations.
Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know
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).
Market Research in Early-Stage Drug Concept and Discovery
During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market...
Simplifying Annual Drug Sample Reporting
Pharma manufacturers and authorized distributors need to submit distribution reports electronically in an eXtensible Markup Language (XML) format to comply with the guidance entitled Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act. This guidance fulfills the Drug Sample Transparency Act specification of ACA Section 6004. These amounts must be reported each year by April 1st for the previous calendar year.
MoCRA: The Future of Cosmetic Regulations
The Modernization of Cosmetics Regulation Act of 2022 overhauls existing regulations, mandating FDA-established Good Manufacturing Practices for cosmetics manufacturers.