Commercial INDs in eCTD Format What it takes for the Paper to eCTD Switchover?

An Investigational New Drug (IND) sponsored by a corporate entity is considered as a ‘Commercial IND.’ Center for Drug Evaluation and Research (CDER) has the authorization to designate IND as commercial if it finds the intent to commercialize the drug in future. In the United States, INDs must be registered with the Food and Drug Administration (FDA). As part of the implementation of FDA’s final notification released on May 5th, 2015 regarding adaption of eCTD formats, Commercial INDs are required to be submitted in eCTD format by May 5, 2018.

With the phase 1 of eCTD submissions completed, the FDA has already stopped accepting paper format for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs) from May 5th, 2017. Under phase II, Commercial INDs along with Drug Master Files (DMFs) are required for eCTD submissions. As the countdown for submissions in eCTD format is coming to an end, here are some of the possible approaches we laid out for conversion of Commercial INDs.

To know more about...Commercial INDs in eCTD Format What it takes for the Paper to eCTD