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Medical Device Safety and Quality
Unique Device Identification (UDI) and Product Data
Drug Label Research
Drug & Biologic Product Submissions
Recent Blog Posts
LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies
HORSHAM, Pa., April 26, 2022 /PRNewswire/ -- Reed Technology and Information Services Inc. (Reed Tech™), a leading...
FDA Drug Distribution Amounts Report: Frequently Asked Questions and More
In late 2021 the US Food and Drug Administration (FDA) is instituting a new annual distribution report, Reporting Amount of...
Public Dashboard Now Available for REMS Data
A new public dashboard has been launched by the Food and Drug Administration (FDA) for public access to data for drugs with...
HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface
Did you know? There are now less than 200 days until the next Class I deadline occurring September 24, 2022. Many in the...
Organizing and Finding Documents Easily for Medical Device Companies, Featuring Greenlight Guru
At Reed Tech Life Sciences, we know the challenges of locating and securing important documentation for both internal and...
How Can You Prepare for Unique Device Identification Product Data Submission in Asia?
Reed Tech subject matter experts, Gary Saner, Information Solutions Senior Manager and Patti Shragher, Medical Device...
What the EU EUDAMED Timeline Means for Your Product and What to Do Now
What is the EU EUDAMED Timeline? The EU EUDAMED Medical Device Registration (MDR) Date of Application (DoA) occurred on May...
LexisNexis® Reed Tech and Greenlight Guru Announce Strategic Alliance to Guide Customers to Market Faster
LexisNexis® Reed Tech has teamed up with Greenlight Guru, the leading Medical Device Success Platform for medical device...
How Does Software as a Medical Device Relate to Unique Device Identification?
Determining Software as a Medical DeviceIt is critical to first determine if the software article is a Device Component, a...
Missed FDA Annual Deadlines? It’s not too late to keep your drug active!
The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year. Most of the...
Is My Product a Medical Device?
A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’....
Updated Deadline: FDA Announces New Annual Drug Distribution Reporting Requirement
The Food and Drug Administration (FDA) has informed industry that the February 15, 2022 date for submitting 2020 data per...
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...
FDA Withdraws 216 ANDAs
Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4 submission deadlines...
Overview of Pharma Annual Deadlines and Requirements
Each year pharmaceutical companies, including both manufacturers and private label distributors, are subject to numerous...
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...
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...
Achieving Compliance: Pharma Year-End Requirements
Each year, regulatory teams must comply with several FDA year-end deadlines. Each company responsible for submitting drug...
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...
Status Update for Australia TGA UDI
Is Australia Therapeutic Goods Administration (TGA) making progress on Unique Device Identification (UDI) requirements? The...
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...
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