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EUDAMED-Now or Later?

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.

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Shaping the Future of Biopharma: Key FDA Decisions & Their Impact on Industry Dynamics

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.

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Reg Ops Radar: eCTD & Regulatory Updates

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.

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Benefits of a Singular Global UDI Vendor

Benefits of a Singular Global UDI Vendor

As we continue to discuss optimal solutions to support the growth and compliance needs of industry, LexisNexis Reed Tech is committed to providing you with a single UDI vendor and platform. As such, here is a detailed analysis that highlights the tangible benefits of opting for a single, global end-to-end solution platform, compared to managing multiple vendor platforms.

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Takeaways from 2024 IBA Cosmetics Convergence

Takeaways from 2024 IBA Cosmetics Convergence

LexisNexis Reed Tech was pleased to sponsor, present, and attend the recent IBA (International Beauty Association) Cosmetics Convergence Spring Symposium. In addition to having great conversations with our industry peers, we attended many educational sessions, especially those concerning the new MoCRA regulations, and are happy to share some highlights here. For more information about MoCRA requirements and deadlines, please contact [email protected]. To learn more about IBA and their upcoming events, please visit their website.

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FDA Plans for Artificial Intelligence and Medical Products

FDA Plans for Artificial Intelligence and Medical Products

AI has the potential to revolutionize healthcare, and the FDA wants to ensure that patient safety remains the top priority while fostering these cutting-edge advancements. That’s where their four areas of focus come in – collaboration, regulatory clarity, standards and best practices and research.

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2024 MoCRA Update: Delays, Enforcement and More

2024 MoCRA Update: Delays, Enforcement and More

As the first US cosmetic regulation in over 80 years is finally being implemented, Reed Tech is keep a close eye on all evolving mandates, requirements and deadlines to communicate all relevant information to our customers. As such, Reed Tech subject-matter experts,...

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Understanding Basic UDI-DI in EUDAMED

Understanding Basic UDI-DI in EUDAMED

By submitting product data to health authority databases, the medical device industry can help ensure the safety and traceability of devices. One crucial element is the European Commission/EUDAMED-specific concept of Basic UDI-DI.

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Revisions to FDA-Forms 365h and 1571

Revisions to FDA-Forms 365h and 1571

The US Food and Drug Administration (FDA) has recently made updates to forms 365h and 1571. Form 365h is “Application to Market a New or Abbreviated New Drug or Biologic for Human Use”. These applications are commonly referred to as NDA, ANDA or BLA. Form 1571 is “Investigational New Drug Application (IND)”. These are among the most important eCTD forms involved in your drug or biologic application process.

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FDA Releases MoCRA Draft Guidance

FDA Releases MoCRA Draft Guidance

On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA. 

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FDA has Updated eCTD Guidance to Recommend Structure-Data Files

FDA has Updated eCTD Guidance to Recommend Structure-Data Files

Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).

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Reed Tech Takeaways from RAPS Euro Convergence

Reed Tech Takeaways from RAPS Euro Convergence

Greetings from Amsterdam! Earlier this month, Sales Development Representative Miriam Kniering represented Reed Tech Life Sciences at the RAPS Euro Convergence conference in Amsterdam. Upon Miriam’s return, we took some time to sit down and ask her a few questions...

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EU Amendment to Extend Legacy Medical Device Transition

EU Amendment to Extend Legacy Medical Device Transition

In recent news, the European Commission passed an extension (EU Regulation 2023/607) to the transition deadline for Legacy Medical Devices to be placed on the EU market. Here is a quick summary of recently posted information about the reasoning behind this decision...

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Coffee Talk with Reed Tech – EU EUDAMED Testing Update

Coffee Talk with Reed Tech – EU EUDAMED Testing Update

In the latest edition of 'Coffee Talk', Reed Tech UDI experts, Gary Saner (Sr. Manager of Information Solutions) and John Lorenc (Director Product Management, Medical Devices), discuss EU EUDAMED access connection issues, who has been affected, what scenarios had...

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Simplifying Annual Drug Sample Reporting

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.

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MoCRA: The Future of Cosmetic Regulations

MoCRA: The Future of Cosmetic Regulations

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law on December 29, 2022. This law, which provides a major overhaul of existing cosmetic regulations, requires the Food and Drug Administration (FDA) to create Good Manufacturing Practices for all cosmetics manufacturers. The law states that these established practices must include mandatory reporting of serious adverse health events caused by cosmetic products and mandatory testing of asbestos levels. This law will also include updates to cosmetic listing requirements.

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Vision Expo West and Eyewear Industry UDI

Vision Expo West and Eyewear Industry UDI

  Reed Tech Life Sciences representative Patti Shragher attended The Vision Expo West 2022 conference, on September 14th – 17th. This year's event took place at the Venetian Convention Center & Expo in Las Vegas, Nevada. We asked a few questions about her...

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Status Update for Australia TGA UDI

Status Update for Australia TGA UDI

The Australia Therapeutic Goods Administration (TGA) has announced several updates to the go-forward plan for implementing UDI compliance   News of note: • TGA has announced that they will have a similar model to the FDA, adopting some elements of the EUDAMED model• A...

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FDA Class I Medical Device UDI Due December 2022

FDA Class I Medical Device UDI Due December 2022

Update on FDA Class I UDI as of July 22, 2022 Final guidance has been issued by the US Food and Drug Administration (FDA) for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI)...

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Preparing, Managing and Monitoring Medical Device UDI

Preparing, Managing and Monitoring Medical Device UDI

In today’s ‘Coffee Talk’ we are chatting with Linda Morehouse, Account Executive with Reed Tech Life Sciences. Linda specializes in helping medical device manufacturers with Unique Device Identification solutions for global health authorities like US FDA, EUDAMED and...

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Public Dashboard Now Available for REMS Data

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 approved Risk Evaluation and Mitigation Strategy (REMS.) According to FDA, This new dashboard includes visualizations and charts for total and...

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Is My Product a Medical Device?

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’. Intended Use and Indications for Use are key determiners and FDA provides clear guidance. Packaging and accessory definitions can be reasons for...

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What is a UDI label and UDI requirements?

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 and version of that device on the market.How Do You Create the UDI?The...

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FDA Withdraws 216 ANDAs

FDA Withdraws 216 ANDAs

Abbreviated new drug applications (ANDAs) are subject to complying with requirements of FDA annual reporting—often the Q4 submission deadlines including blanket no-change certification (BNCC) or establishment registration (ER). Due to non-compliance with these annual...

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Overview of Pharma Annual Deadlines and Requirements

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. Though every company is different and each situation is unique, the...

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FDA GUDID Class I Reminder

FDA GUDID Class I Reminder

(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID? It is a database that contains key device information submitted to the FDA, including Unique Device Identifier (UDI) product data. Within the FDA...

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New Drug Application (NDA): Back to the Basics

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 vehicle through which drug sponsors formally propose that the FDA approve a...

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Customer Q&A: OMUFA Update

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, Carolina Wirth, Of Counsel, Arnall Golden Gregory LLP to discuss these...

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China NMPA UDI and Device Registration Basics

China NMPA UDI and Device Registration Basics

In China, key regulatory policies originate with the State Council (Executive Branch). At the policy level, regulations for medical devices started in 2016 with a five-year plan. For regulatory compliance, typically there is a registration process, clinical evaluation...

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Why You Need a UDI Specialist

Why You Need a UDI Specialist

Did you know there are multiple health authorities around the globe with current or future requirements for medical device product data specifically for Unique Device Identification (UDI) standards? The list continues to grow (US FDA, EU EUDAMED, South Korea MFDS,...

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OTC Monograph Fees Announced… Not so fast!

OTC Monograph Fees Announced… Not so fast!

Co-Authored by David Wilson, Sr. Account Executive, Reed Tech, and Carolina Wirth, Of Counsel, Arnall Golden Gregory, LLP On December 29, 2020, the U.S. Food and Drug Administration published a Federal Register notice setting the fee rates under the Over-the-Counter...

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UDI Assignment for Spectacle Lenses & Readers in EUDAMED

UDI Assignment for Spectacle Lenses & Readers in EUDAMED

Are makers of eyewear products subject to Unique Device Identification (UDI) requirements for compliance with EUDAMED? Recent news would indicate the answer is ‘yes’. For those manufacturers of eyewear lenses and frames, a recently posted guidance document from the EU...

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The Anatomy of a National Drug Code (NDC)

The Anatomy of a National Drug Code (NDC)

Per the Drug Listing Act of 1972, part of the Food and Drug Administration (FDA) requirement to electronically list drug products (Rx and OTC) includes the assignment of a National Drug Code (NDC). An NDC is a 10 digit number that uniquely and universally identifies a...

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Electronic Drug Listing and Registration Guides

Electronic Drug Listing and Registration Guides

To learn the main requirements for Electronic Drug Registration and Labeling (eDRL), download a quick-reference guide with step-by-step instructions and ways to simplify and expedite the process. Download your free guide here. The eDRL How-to Guide answers questions...

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UDI and 21 CFR Part 11

UDI and 21 CFR Part 11

Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...

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Fact vs Fiction: UDI in China and Global Data Pools

Fact vs Fiction: UDI in China and Global Data Pools

Introduction The National Medical Products Administration (NMPA) is the regulating body in China for drugs and medical devices. The NMPA is the authoritative group that drafts laws and regulations for drugs, medical devices, and cosmetics. They also establish medical...

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Global Data Synchronization Network

Global Data Synchronization Network

Why your product data needs to be in GDSN…NOW! If you manufacture medical devices, you know the challenges in managing accurate, current, and complete product data and sharing it with your trading partners. Your data consumers, both internal and external, trust your...

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Fact vs Fiction: GDSN Connection

Fact vs Fiction: GDSN Connection

Author: John Lorenc, Sr. Manager Regulatory Solutions, Reed Tech Fiction:  Most global health authorities subscribe to a GDSN data pool, therefore, UDI compliance can be achieved by a standard GDSN data pool publication. Fact:  One of the largest health authorities,...

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Reed Tech Insights: US FDA and EU EUDAMED Comparisons

Are data elements for EU EUDAMED similar to US FDA for unique device identification (UDI) submission? The short answer is, 'not exactly.' In this series of Reed Tech Insights, we take a deep-dive into the UDI data attributes of US and EU in specific areas, noting the...

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Meet the Team at Reed Tech – Patti Shragher

Patti Shragher Account Executive, Reed Tech Life SciencesPatti enjoys solving problems with technology and takes pride in strategic challenges. She consults with customers and prospects all over the globe on Reed Tech solutions for regulatory compliance, product data...

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Meet the Team at Reed Tech – Andrew Pfeifer

Andrew Pfeifer Senior Account Executive, Reed Tech Life SciencesAndrew is an experienced guiding force for medical device professionals, having spent the last 5 years in UDI related applications. He specializes in understanding the complexities of product data...

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UDI Implementation Tips and GDSN Data Management

UDI Implementation Tips and GDSN Data Management

Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management By: John Lorenc, Senior Manager Regulatory Solutions — Life Sciences Reed Tech Tracking medical devices throughout the healthcare supply chain and delivery system has proven...

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What is a GLN (Global Location Number)?

What is a GLN (Global Location Number)?

Global Location Number (GLN) A Global Location Number (GLN) is a 13 digit number that acts as a key for identifying the location, whether physical or digital, and the function or entity of a company across the supply chain. A GLN gives companies complete flexibility...

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Use GDSN to Increase Your Corporate Value

Use GDSN to Increase Your Corporate Value

What is the Global Data Synchronization Network? The GDSN is the largest online product data network. It’s a secure network that allows any agents, such as manufacturers, retailers, distributors, and wholesalers to share validated product information. Because of its...

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UK NHS eProcurement: The What, Who, Why and When

If your organization markets medical devices in the United Kingdom, you may have heard about the National Health Service (NHS) eProcurement program. Sometimes loosely referred to as the “U.K. UDI,” eProcurement shares some traits with FDA’s UDI program, but is quite...

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GS1 UDI – How GDSN, GTIN, & GS1 Affect UDI

If you are involved in your organization’s compliance program for Unique Device Identification (UDI), you have probably heard a lot of “G terms” being thrown around, such as “GS1,” “GTIN” and “GDSN.” But what do these terms mean and where do they fit in with UDI...

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UDI Data Security: Why it should be important to you

Data security has three facets—confidentiality, integrity and availability. Device labelers need to keep each of these areas in mind when it comes to managing the UDI data for their device portfolio. Confidentiality: Not all data you submit to FDA as part of a UDI...

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A Risk-Based Approach to UDI Compliance

As medical device manufacturers scramble to meet Unique Device Identification (UDI) deadlines, a risk-based approach to UDI compliance will help ensure continuity within the quality system, consistency in UDI practice and application, accuracy of the associated data...

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UDI: How do I assign Device Identifiers?

As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to your products and how to make sense of the different levels of DIs in a single GUDID record. These are questions we receive from industry members all...

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FDA GUDID UDI compliance: Accuracy required

Unique Device Identification (UDI) product data submissions require not just that your system for sending data to the FDA’s Global Unique Device Identification Database (GUDID) be in place and functioning smoothly. It requires that the data you send through that...

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GUDID Account Creation: Five Steps to Follow

When medical device manufacturers prepare to submit their device data to the FDA in compliance with Unique Device Identification requirements, one of the prerequisite steps for all manufacturers is to establish a Global Unique Device Identification Database account....

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What Your CEO Needs to Know about UDI

Leaders of the regulatory and labeling departments of a medical device manufacturer likely know that complying with the FDA’s final rule on Unique Device Identification (UDI) takes time and planning. But convincing the executives in the C-suite to allot the necessary...

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Step 1 in UDI Compliance: Assembling the Right Team

After working with a number of medical device companies to successfully submit device records to the FDA, one important piece of advice from the experts at Reed Tech is to start by gathering the right team members from the beginning. Initially, many in the medical...

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4 Questions to Ask Before Choosing a UDI Issuing Agency

As Implantable, Life-Sustaining and Life Supporting (I/LS/LS) and Class II medical device labelers have complied with the FDA’s final rule on Unique Device Identification (UDI), one of the first major decisions they needed to make: choose a device identifier (DI)...

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UDI Data Submission: Who is Responsible?

As part of the FDA’s Unique Device Identification (UDI) mandate, medical device labelers are required to submit a data record for the devices they market in the United States to the FDA’s Global Unique Device Identifier Database (GUDID). But who does the FDA consider...

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