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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.
July 31st Deadline Approaching for CARES Act Report
The FDA CARES Act requires drug manufacturers, repackers and relabelers to submit annual reports on drug production volumes. Here are the key points: Deadline: July 31, 2024, for the 2023 calendar year; Who Must Report: All FDA-registered facilities under section 510(j)(3) of the Federal Food, Drug & Cosmetic Act; What to Report: Annual production volumes for each listed drug.
EUDAMED-Now or Later?
With the EUDAMED go-live date rescheduled multiple times, manufacturers face conflicting strategies of when to make UDI/Device registration submissions to EUDAMED.
Shaping the Future of Biopharma: Key FDA Decisions & Their Impact on Industry Dynamics
The biopharma industry is poised for significant transformation in the coming years, with several critical FDA decisions expected in the near future. These decisions will not only impact individual companies and products but have far-reaching implications for the entire industry— shaping market dynamics, investment strategies and the trajectory of innovation. As industry leaders navigate this complex landscape, they must remain vigilant of FDA’s actions and adapt their strategies to capitalize on emerging opportunities while mitigating potential risks.
LexisNexis® Reed Tech expands MedTech Regulatory Compliance Solutions and Services for medical device companies
LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to a varied suite of regulatory compliance solutions and services to support medical device manufacturers, distributors, and related operations.
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...