Reminder: Establishment Registration Renewals are Due by EOY
Oct02

Reminder: Establishment Registration Renewals are Due by EOY

FDA Establishment Registration renewals for 2019 must be submitted between October 1 and December 31. With certain exemptions, any establishment engaged in the manufacture, repacking, relabeling, or salvaging of a drug product for commercial distribution is required to register with FDA annually. Registration is required within five days of introducing a product into commercial distribution.

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FDA’s New ANDA Submissions Guidance: Key Points
Sep27

FDA’s New ANDA Submissions Guidance: Key Points

The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA. The primary purpose of this guidance is to help industry increase the quality and suitability of electronic common technical document (eCTD) submissions by identifying the information that an applicant should include to ensure that a complete, high-quality application is submitted to FDA.

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Updated EU eCTD Validation Criteria
Aug28

Updated EU eCTD Validation Criteria

The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018.  The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account. 

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New 3rd Acknowledgement for ESG Users
Aug21

New 3rd Acknowledgement for ESG Users

Beginning September 4, 2018, a new third Acknowledgement for ESG users will be sent for all submissions sent to the CBER in eCTD format.

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Updated Form FDA 1571
Aug07

Updated Form FDA 1571

FDA has updated Form FDA 1571 again and posted a new version to the FDA Forms web page, replacing the previous version, released in April 2018.

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Updates to Common FDA Forms
May10

Updates to Common FDA Forms

We recently posted about the August 2017 updates to common FDA forms included in eCTD submissions. Well, they’ve been updated yet again. Several FDA forms are now showing a revision date of April 2018, including: Form FDA 356h Form FDA 1571 Form FDA 3674 The easiest way to ensure that you’re using the current version of these forms is to download new copies directly from the FDA Forms page on FDA’s website. If you already have...

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