CBER updates two guides for staff on reviewing INDs and handling clinical holds
The US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has updated two internal policy guides for its staff. The first guide outlines the procedures for processing and reviewing investigational new drug applications (INDs), while the second details the procedures for handling clinical holds for INDs.Both updates provide additional details on the processing and review of INDs that reference a drug master file (MF); the guides went into effect on 14 January 2026.
The first guide, Standard Operating Policy and Procedures (SOPP) 8217, version 6, addresses the administrative processing of INDs, including those for expanded access, except for emergency use requests. This latest version includes additional information in the policy section regarding the procedures for reviewing a drug master file (MF) in an IND submission.
FDA defines MFs as providing “confidential, detailed information about facilities, processes, components, raw materials, etc., which may be used in the manufacture, processing, packaging, and storage of one or more biologic, drug, and device products. A MF allows a manufacturer to protect its intellectual information from disclosure to its development or manufacturing partner while complying with regulatory requirements for disclosure of manufacturing process information to the Agency.”
The guide states that “a third party (i.e., a person or an entity other than the sponsor) who intends to submit information to FDA to be used to support an IND without disclosing their confidential/proprietary/trade information to the IND sponsor may submit a Master File (MF) which also includes a Letter of Authorization (LOA) to FDA. The LOA will permit FDA to review the information in the MF in support of the authorized party’s regulatory submission.”
The guide also refers sponsors to SOPP 8301: Receipt and Processing of Master Files and SOPP 8301.1: Review and Administrative Procedures for Master Files for additional information regarding MFs.
In other changes, the guide also adds an artificial intelligence (AI) reviewer from the Office of Biostatistics and Pharmacovigilance (OBPV) to the IND review team.
Clinical holds
A second SOPP guides CBER staff on processing clinical holds for an IND. This revision includes references to deficient MFs that support an IND.
It states that “If during the review, the MF is deemed to be deficient to support a specific referencing IND, a ‘Master File Deficiency Letter’ will be sent to the MF holder. FDA will notify the IND sponsor that the MF is insufficient to support their submission. The general subject of the deficiency may be identified to the IND sponsor, but no confidential and proprietary information in the MF will be disclosed. The details of the MF deficiency are disclosed only to the MF holder while protecting the confidential information contained in the IND. The IND sponsor and the MF holder should be advised to communicate directly with each other as soon as possible regarding how the deficiencies can be addressed."
CBER SOPP on administrative processing
CBER SOPP on clinical holds
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