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What Global Manufacturers Need to Know About 2026 UDI Enforcement
April 28, 2026
What Global Manufacturers Need to Know About 2026 UDI Enforc...
US FDA Class I UDI Submission Deadline
February 22, 2026
US FDA Class I UDI Submission Deadline
FDA Releases MoCRA Draft Guidance
August 10, 2023
FDA Releases MoCRA Draft Guidance
LexisNexis Life Sciences Solutions and ONIX Life Sciences Expand Strategic Alliance to Guide Pharma Customer to Market Faster
February 21, 2026
LexisNexis Life Sciences Solutions and ONIX Life Sciences Expand...
DMFs, Manufacturer Listings, and eCTD Submissions: Avoiding Common Regulatory Pitfalls
June 18, 2026
DMFs, Manufacturer Listings, and eCTD Submissions: Avoiding Common...
FDA Final Rule: Preparing for the Transition to a 12-Digit NDC
March 11, 2026
FDA Final Rule: Preparing for the Transition to a 12-Digit N...
 

Articles

FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars

FDA Finalizes Guidance on Promotional Labeling for Biologics...

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...

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Swissmedic Launches UDI Module in swissdamed

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...

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