In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this blog post, we’ll help you catch up on anything you may have missed.

Update – eCTD Validation Criteria

On May 11, FDA updated their eCTD validation criteria. In addition to providing some clarifications, they introduced a new error.

1738, STF Study ID should match STUDYID or SPREFID listed in the referenced Trial Summary (ts.xpt) file

Ensure ts.xpt is referenced under the correct STF. If ts.xpt is under the correct STF, update the STUDYID or SPREFID in the ts.xpt and other referenced study data files. Modify your SOPs to ensure that a consistent Study ID (exact match) is used.

Final – Promotional Labeling and Advertising Materials Submission

Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs; Guidance for Industry became effective in April 2022. It pertains to submissions of promotional materials for human prescription drugs (drugs) to the Food and Drug Administration (FDA or the Agency) made by manufacturers, packers, and distributors (firms), whether the applicant or an entity acting on behalf of the applicant.

Specifically, this draft guidance pertains to submissions made to the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER), and explains certain aspects of electronic submission of promotional materials in module 1 of the electronic Common Technical Document (eCTD) using version 3.3 or higher of the us-regional-backbone file.

Update – Providing Regulatory Submissions in Alternate Electronic Format

In June, FDA re-issued “Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry” (relates to any submission with an exemption or a waiver from filing in eCTD format).

Final – Providing Submissions in Electronic Format— Postmarketing Safety Reports

In April, FDA published Providing Submissions in Electronic Format—Postmarketing Safety Reports; Guidance for Industry.

This guidance assists industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance provides general information on the electronic submission of postmarketing safety reports under the following provisions:

• 21 CFR 314.80 and 314.98 Products with approved NDAs or ANDAs₂
• 21 CFR 600.80 Products with approved BLAs
• 21 CFR part 4, subpart B (additional reports for combination products with approved NDAs, ANDAs, or BLAs)

Final – Update to Technical Conformance Guide for IND Safety Reports

FDA has issued a final version 1.1 of “Electronic Submission of IND Safety Reports Technical Conformance Guide” providing specifications, recommendations, and general considerations on how to submit electronic IND safety reports to CBER and CDER. Significant updates include:

• Added information regarding data elements needed for IND safety reports from aggregate analysis
• Included provisions for submitting names of products without established names to the IND prior to electronic submissions to FAERS

Draft – Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.

The FDA has published a Request for Comments on the Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange. This document provides a draft design of HL& FHIR profiles that contain the data elements and terminologies associated with PQ/CMC subject areas and scoped to some of what is currently submitted in Module 3 of the eCTD submission. The comment period for this document closed on May 17^th.

Draft – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

In April, FDA published a first draft of “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff”.

This guidance is intended to provide recommendations to industry regarding cybersecurity device design, labeling, and the documentation that FDA recommends be included in premarket submissions for devices with cybersecurity risk. 

Although FDA issued final guidance addressing premarket expectations in 2014 and a draft guidance in 2018, the rapidly evolving landscape, and the increased understanding of the threats and their potential mitigations, necessitated an updated approach. 

Additional Planned Guidance

There’s still more to come in 2022. For the latest, see FDA Planned Guidance (CDER Guidance Agenda New & Revised Draft Guidance Documents Planned for Publication in Calendar Year 2022), which was updated in July.