Agency IQ

JUNE 16, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014. Specifically, all NDCs will be required to be 12 digits in length with three distinct segments.

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Agency IQ

OCTOBER 27, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

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Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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FDA Science Regulations Production 40

Agency IQ

JULY 12, 2024

Fall 2023 July 2024 Final Rule Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices Fall 2022 July 2024 Final Rule Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail (..)

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Regulations FDA Science Production 40