June 18, 2026

DMFs, Manufacturer Listings, and eCTD Submissions: Avoiding Common Regulatory Pitfalls

Drug Master Files, manufacturer listings, and Electronic Common Technical Document (eCTD) submissions are foundational to regulatory compliance. Yet even experienced regulatory, quality, and operations teams can encounter avoidable errors that delay approvals, create agency questions, and trigger costly rework. As global requirements continue to evolve across the FDA, EMA, Health Canada, and other regulatory authorities...

April 28, 2026

What Global Manufacturers Need to Know About 2026 UDI Enforcement

The global Unique Device Identification (UDI) landscape is entering a critical enforcement phase — and 2026 will be a challenging year for medical device manufacturers operating in the European Union, Australia, and Switzerland. Health authorities are migrating from system development/launch to system enhancement/maintenance and placing more attention on active oversight and industry mandatory compliance. For...

March 11, 2026

FDA Final Rule: Preparing for the Transition to a 12-Digit NDC

The FDA’s final rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” establishes a uniform 12-digit format for FDA-assigned National Drug Codes (NDCs) . This change will standardize how drugs marketed in the U.S. are identified and requires action across the pharmaceutical supply chain. What’s Changing? Currently, FDA assigns 10-digit NDCs in multiple formats...

February 22, 2026

US FDA Class I UDI Submission Deadline

UDI product data is now due for specific scenarios (enforced as of December 8, 2022). Class I and Unclassified medical devices that are required to be labeled with a UDI code must submit product data to the FDA GUDID — the enforcement date began December 8, 2022. Note that the FDA has provided a Final Guidance outlining exceptions for “Consumer Health Products,” i.e., certain Class I devices that...

February 21, 2026

LexisNexis Life Sciences Solutions and ONIX Life Sciences Expand Strategic Alliance to Guide Pharma Customer to Market Faster

LexisNexis Life Sciences Solutions and ONIX expand strategic alliance to guide pharma customers to market faster Professionals in the life sciences industry rely on unique regulatory affairs expertise to effectively manage the full end-to-end Electronic Common Technical Document (eCTD) process. LexisNexis Life Sciences Solutions, a leading provider of data management and analytics solutions for the life sciences industry...

January 26, 2026

FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars

On December 9, 2025, the US Food and Drug Administration (FDA) finalized guidance on promotional labeling and advertising for biologics, biosimilars, and interchangeable biosimilars. The guidance aims to ensure that promotional materials are accurate, truthful, and not misleading. It also gives industry clearer direction on FDA’s expectations. The guidance applies to biologics approved under section 351(a) of...

November 21, 2025

Printed Drug Labeling Requirements Remain in Effect

As of today, U.S. Prescribing Information (USPI) must still be distributed to prescribing healthcare professionals in printed paper format. Despite ongoing discussions around digital transformation and electronic product information, the requirement for printed labeling remains in place under current federal law. This means pharmaceutical manufacturers are still responsible for composing FDA-approved USPI content into...

September 05, 2025

Swissmedic Launches UDI Module in swissdamed

Swissmedic has launched the Unique Device Identification (UDI) module within the swissdamed database (Swiss Database on Medical Devices) . Since August 2025, manufacturers, importers, and authorized representatives can voluntarily submit medical devices, systems, and procedure packs into swissdamed. This launch marks a major step in Switzerland’s medical device regulatory framework. It also brings swissdamed closer...

March 24, 2025

Health Canada’s Progress on Implementing the XML Product Monograph Requirement

Health Canada continues to make strides in modernizing the way pharmaceutical product information is structured and shared. As part of its digital transformation efforts, the agency is advancing the implementation of the XML Product Monograph (XML-PM) requirement, which is set to enhance efficiency, accessibility, and interoperability of drug labeling information across the industry. What is the...

February 19, 2025

Missed FDA Annual Deadlines? It’s not too late to correct your listings!

The Food and Drug Administration (FDA) requires drug manufacturers to keep their listings updated each year, with most deadlines falling on December 31st. When a manufacturer misses these deadlines, the drug is at risk of becoming inactive. The FDA has sent notices of intent to inactivate outdated drug listing records, explaining that affected drugs would become inactive by the end of January 2025. Why is my drug becoming...

January 15, 2025

FDA Updates Guidance on GUDID and GMDN Codes: What You Need to Know

FDA updates guidance on GUDID and GMDN codes: what manufacturers need to know The FDA has introduced significant updates impacting the medical device industry, specifically targeting Global Medical Device Nomenclature (GMDN) Codes compliance in the Global Unique Device Identification Database (GUDID). These changes aim to improve standardization and ensure accurate device classification. Below, we summarize the latest...

October 10, 2024

UDI Labeling (Unique Device Identification): Best Practices

UDI labeling best practices for medical device manufacturers Unique Device Identification (UDI) labeling remains a hot topic among medical device manufacturers under pressure to comply with UDI requirements for US FDA GUDID and other emerging health authorities around the globe. EU EUDAMED is underway and China’s NMPA, South Korea and others have published guidelines. UDI is becoming integrated into medical device...

October 10, 2024

UDI Regulations from EU, US, and other Global Regions

UDI regulations: global updates from health authorities In recent years, Unique Device Identification (UDI) regulations have been a focus topic for global health authorities. These regulations enhance patient safety, improve supply chain management, and facilitate efficient medical device recalls. Read on for a recap of recent updates and expected changes to UDI regulations from global health authorities: USA In...

October 01, 2024

Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) introduced reforms to the OTC drug review process. As of October 1, 2024, the listing of OTC monograph drug products requires the use of the current Marketing Category and Application Number values in the FDA’s Electronic Drug Registration and Listing System (eDRLS) and can no longer be certified under the old marketing categories and old application...

July 15, 2024

EUDAMED-Now or Later?

EUDAMED now or later? UDI/Device registration strategy for manufacturers With the EUDAMED go-live date rescheduled multiple times, manufacturers face conflicting strategies of when to make UDI/Device registration submissions to EUDAMED. Though a few may ignore the facts and think (hope) that EUDAMED will never happen, the critical question is not Will EUDAMED become mandatory, but When will EUDAMED become mandatory...

April 24, 2024

​​Expert Insights on the EU Proposed Legislation EUDAMED Rollout​-Approved

EU proposed legislation and EUDAMED rollout On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). We asked our in-house expert, Gary Saner, to explain the proposed changes and how they might affect medical device manufacturers. As of April 25, 2024, the EC has approved the amendment...

November 27, 2023

Understanding Basic UDI-DI in EUDAMED

By submitting product data to health authority data bases, the medical device industry can help ensure safety and traceability for devices. One crucial element is the European Commission/EUDAMED-specific concept of Basic Unique Device Identifier – Device Identifier (Basic UDI-DI). This blog will examine what Basic UDI-DI means, why it is essential, and how it plays a role in product data submissions to EUDAMED....

November 23, 2023

​​Update on EUDAMED Timeline​

EUDAMED timeline update: what medical device manufacturers need to know Understanding EUDAMED EUDAMED is an online system that aims to centralize and harmonize the data related to medical devices across the European Union. It is a vast repository containing information on medical devices, manufacturers, clinical investigations, market surveillance, and other critical data. The overarching goal of EUDAMED is to strengthen...

August 23, 2023

Health Canada Releases XML PM Draft Guidance

Following a lengthy period of anticipation, Health Canada has released Draft Guidance Document Preparation of the Product Monograph in Extensible Markup Language (XML) Format and sample files. Along with the draft guidance, Health Canada has opened a comment period, scheduled to conclude on November 5, 2023. According to Health Canada, the purpose of this guidance is to assist sponsors in developing a product monograph...

August 10, 2023

FDA Releases MoCRA Draft Guidance

FDA releases MoCRA draft guidance on cosmetic facility registration and product listing 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...

July 25, 2023

FDA has Updated eCTD Guidance to Recommend Structure-Data Files

FDA has updated eCTD guidance to recommend structure-data files In November of 2022, the Food and Drug Administration (FDA) published a new version of the eCTD Technical Conformance Guide , amending it to include a new section. This new section, 3.3.3, focuses exclusively on structure-data files. According to the new section, “Depending on the needs of the submission, include chemical structures of drug substances...

June 13, 2023

Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID

The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database ( GUDID ). As a medical device manufacturer or other organization responsible for reporting medical device UDI information to the GUDID, i.e., a Labeler, you may be affected by these initiatives and need to react promptly. Medical devices missing...

March 25, 2023

Health Canada Now Requiring Second-Language at Post-Authorization Phase

Health Canada second-language product monograph requirements 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...

December 13, 2022

New FDA Requirement: New and Updated REMS Files to be Submitted in SPL Format

As of December 28, 2022, all new REMS (Risk Evaluation and Mitigation Strategy) submissions and all REMS updates are required to be submitted in SPL (Structured Product Labeling) format per the FDA. This is in compliance with the Final Guidance on REMS issued by FDA in late December 2020. This means that any current REMS registrations will not need to be submitted in SPL until they require updates. There are currently...

August 11, 2022

Combination Products: Regulatory Requirements and How To Comply

Combination products: regulatory requirements and how to comply Combination Products continue to be at the forefront of regulatory chatter. Our customers, both medical device and pharmaceutical, are regularly coming to us with questions surrounding this topic. How do I decide if my product is a combination product? What are the regulations for a combination product? What submissions do I need to make for a regulatory...