New instructions for Form FDA 1571 Field 6B

Today, the U.S. Food and Drug Administration (FDA) released an update to the Form FDA 1571 instructions. This update further clarifies when Research or Commercial IND should be selected for Field 6B: IND Type and thus, when eCTD requirements will apply.

The instructions for Form FDA 1571 previously stated:

“Select Research IND if the product under investigation is not intended to be commercialized at a later date. Research INDs are generally sponsored by individual investigators, academic institutions and non-profit entities. May include INDs for emergency use and expanded access. (21 CFR 312.305 and 312.310)”

The Form instructions now include the following additional information regarding selection of the proper type of IND:

“When a sponsor that generally submits Research INDs, then submits either a Phase 2 or Phase 3 protocol, they should select “Commercial” (eCTD requirements will apply). However, when the sponsor believes the Phase 2 or Phase 3 protocol is still solely for research, the sponsor may submit a justification explaining their rationale in the cover letter, along with the protocol. If the FDA agrees, then the IND will remain a “Research” IND and the eCTD requirements will not apply. Note that in all cases, expanded access INDs and protocols should be marked as “Research” on the Form 1571 and are exempt from eCTD requirements.”

For more information, please visit the following resources:

• FDA Forms webpage
• Electronic Common Technical Document (eCTD)
• Expanded Access: Information for Industry

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