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FDA Changes to Drug Listing Process for Contract-Manufactured Products


FDA Changes to Drug Listing Process for Contract-Manufactured Products

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The FDA recently introduced two significant changes to its process for drug listing products manufactured by contract manufacturing organizations (CMOs). It is important for CMOs and Private Label Distributors (PLDs) to understand these changes and make sure they update their internal processes in order to ensure successful drug product listing submissions going forward. Change #1 […]

Webinar: FDA Expectations for Biologic Lot Distribution Reporting

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David Wilson of Reed Tech discusses FDA requirements for Biologic Lot Distribution Reports (LDR) and what industry has learned three years since the electronic SPL mandate. WATCH NOW TO LEARN: LDR background and history Electronic submission timelines and formatting requirements How LDR fits into the SPL submission roadmap Strategies for compliance

You Missed the Drug Listing No Change Certification Deadline…Now What?

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You may have seen one of our recent posts about the FDA’s new Blanket No Change Certification submission requirement for drug products. If not, you can get a quick rundown of the requirements here. To help track compliance with the new requirements, FDA has added a field to its downloadable NDC Database File showing the […]

Webinar: FDA’s No Change Certification for Drug Products

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In this webinar, you’ll get an overview of the requirements for FDA’s new Blanket No Change Certification submission type for drug product listings. Presenter Jon Nolan will address the following: What’s Changing Requirements and Timelines Questions from the Audience   Please complete the form to view the webinar recording:

FDA’s New Drug Product Listing Blanket No-Change Certification

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As part of the 2016 Final Rule on Electronic Drug Listing, FDA introduced important new changes that affect all human drug product labelers and manufacturers. Beginning in 2017, every existing human drug product listing must be either 1) updated during the course of the year to reflect changes or 2) certified as current through the […]

Webinar: FDA Annual Reporting Period for Drug Products

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In this webinar, you’ll get an overview of the FDA’s requirements for submissions during the annual reporting period to the electronic Drug Registration and Listing (eDRL) system. That includes drug product site Establishment Registrations and a brand new submission type, the Blanket No Change Certification for drug product listings WATCH NOW FOR: High Level eRDL […]