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Explore our library of blogs, short videos, virtual event recordings and training topicsKnowledge Center Categories
Medical Device Safety and Quality
Global Data Synchronization Network (GDSN)
UDI and Product Data
Drug & Biologic Product Submissions
Recent Blog Posts
What is a UDI label and UDI requirements?
What is UDI? Unique Device Identification is a globally unique, unambiguous identification comprised of a Device Identifier (DI) and a Production Identifier (PI). UDI is specific to a device model...
FDA Withdraws 216 ANDAs
Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual...
Overview of Pharma Annual Deadlines and Requirements
Each year pharmaceutical companies, including both manufacturers and private label distributors, are subject to numerous guidances and mandates to develop and maintain compliance with the FDA....
More medical device recalls predicted in the ‘Predicting Recalls Model’
More of the moment news concerning medical device recalls is appearing in the headlines. We checked the ‘Predicting Recalls Model’ and yes, more current recalls are scoring a ‘1’ in the model,...
Proposed Changes to OTC Sunscreen GRASE and Labeling Regulations
The FDA has proposed new changes to the regulations regarding over-the-counter sunscreen products. Perhaps the most impactful change to manufacturers, the FDA seeks to significantly decrease the...
Achieving Compliance: Pharma Year-End Requirements
Each year, regulatory teams must comply with several FDA year-end deadlines. Each company responsible for submitting drug product listings will have its own unique schedule for submission to FDA...
Recall Prediction: Cardinal Health Monoject Flush Prefilled Syringes
The Recall Prediction Model data continues to show promise as we see additional prediction markers for active recalls in the market. On August 23rd, FDA logged public information for a recall of...
Status Update for Australia TGA UDI
Is Australia Therapeutic Goods Administration (TGA) making progress on Unique Device Identification (UDI) requirements? The answer is yes! There are several progress milestones that have been...
FDA Class I Medical Device UDI Due Sept 2022
Update on FDA Class I UDI On July 1, 2020 the US Food and Drug Administration (FDA) issued a Guidance document for labelers of Class I medical devices. In an effort to help the industry remain...
Over-the-Counter Drug Product Monographs: Cosmetics and Other Combination Focus
Background We recently hosted the sixth in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. The series has taken place...
Medical Device Classifications in Global Markets and Health Authorities
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements of multiple regulatory agencies. An important component of achieving regulatory...
FDA GUDID Class I Reminder
What are the requirements for Class I medical devices concerning unique device identification (UDI) data submission to US FDA GUDID? First off, what is the Global Unique Device Identification...
Predicting Recalls Model and a Real-World Example
Recent events are providing the opportunity to test out the concept of ‘predicting recalls’ using publicly available data. Reed Tech has been conducting a long-term project with a ‘Recall Prediction...
Over-the-Counter Drug Product Monographs: FDA Requirements for Homeopathic Products
Reed Tech recently hosted the fifth in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. The series has taken place...
EU’s Requirement for Implant Cards Provides Key Information for Patients
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices, as prescribed in Article 18 of Regulation (EU) 2017/745 on medical devices. The...
Over-the-Counter Drug Product Monographs: FDA Requirements for Oral Pharma Products
Background We recently hosted the fourth in a series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues. For more fundamental...
New Drug Application (NDA): Back to the Basics
What is a New Drug Application (NDA)?Every new drug in the United States needs to come to market through a New Drug Application with the FDA. According to the FDA, “The NDA application is the...
LexisNexis Reed Tech Life Sciences receives ISO/IEC 27001:2013 certification for international information security standard
ISO 27001 is the leading international standard for information security management systems (ISMS) and thus the most important cyber security certification. It defines the requirements for the...
Over-the-Counter Drug Product Monographs: FDA Requirements for Topical Pharma Products
Background Reed Tech recently hosted the third in a series of OTC-focused webinars featuring in-house subject-matter experts and some of our industry friends and colleagues. The series is scheduled...
Video: How to Efficiently Share Medical Device Product Data through GDSN
What is the Global Data Synchronization Network? The Global Data Synchronization Network (GDSN) is the electronic information highway that connects medical device manufacturers, distributors and...
Customer Q&A: OMUFA Update
Recently, Reed Tech has been receiving many questions from our Pharma customers regarding the Over-The-Counter Monograph User Fee Program. As a response, we enlisted our colleague and friend,...
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