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Reed Tech® Introduces Reed Tech Navigator™ for Drug Labels


Reed Tech® Introduces Reed Tech Navigator™ for Drug Labels

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Horsham, Penn. – July 9, 2018 – Reed Technology and Information Services Inc. (Reed Tech), a provider of high-quality data management and analytics solutions for the life sciences industry, announces the launch of Reed Tech Navigator™ for Drug Labels. Navigator for Drug Labels is a research solution designed to enable in-depth search, monitoring and analysis of drug […]

FDA Drug Listing: When You Need a Manual Override

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One of the great things about the FDA’s electronic Drug Registration and Listing System (eDRLS) is the automatic data validation process. When you submit a Structured Product Labeling (SPL) file to the FDA over the Electronic Submissions Gateway (ESG), the contents are automatically checked against the SPL schema and FDA business rules. If a file […]

Webinar: FDA Drug Listing Requirements for Manufacturers & Distributors

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Join Jon Nolan and Gary Saner of Reed Tech to learn about FDA requirements for electronic Drug Listing and their application to Contract Manufacturing (CMO) and Private Label Distributor (PLD) organizations. WATCH NOW FOR: Electronic Drug Listing Environment History and Future Trends Requirements Overview for Contract Manufacturers and Private Label Distributors Recent FDA Changes to […]

Structured Product Monograph: Health Canada Plants its SPL Flag

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In 2016, Health Canada announced its intention to adopt a structured format for its drug product monographs. In harmonization with international data standards, Canada selected the HL7 Structured Product Labeling (SPL) authoring standard for its product monograph submissions. The program, called Structured Product Monograph (SPM), falls under the agency’s Health Products and Food Branch (HPFB), […]

FDA Changes to Drug Listing Process for Contract-Manufactured Products

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The FDA recently introduced two significant changes to its process for drug listing products manufactured by contract manufacturing organizations (CMOs). It is important for CMOs and Private Label Distributors (PLDs) to understand these changes and make sure they update their internal processes in order to ensure successful drug product listing submissions going forward. Change #1 […]

Webinar: FDA Expectations for Biologic Lot Distribution Reporting

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David Wilson of Reed Tech discusses FDA requirements for Biologic Lot Distribution Reports (LDR) and what industry has learned three years since the electronic SPL mandate. WATCH NOW TO LEARN: LDR background and history Electronic submission timelines and formatting requirements How LDR fits into the SPL submission roadmap Strategies for compliance