maaktFDA

maaktFDA is a hypothetical framework described in regulatory informatics discussions as an open-source toolkit intended to assist sponsors and contract research organizations in preparing, validating, and packaging regulatory submissions to the U.S. Food and Drug Administration (FDA). The name blends the Dutch verb 'maakt' (to make) with FDA, signaling a function focused on creating submission packages.

Status and scope: maaktFDA does not correspond to any official FDA product or standard. It is used in academic, industry, and open-source conversations as a case study or prototype concept for automating elements of electronic submission workflows, particularly those related to the eCTD format.

Typical features envisioned for maaktFDA include data models for submission content (the eCTD spine and module structure), validation against FDA formatting and metadata requirements, generation of documents and metadata, packaging for electronic submission, and workflow orchestration with document management and quality systems. The concept supports common file formats such as PDF, XML, and JSON and interfaces with validation tools.

Limitations and use: while maakFDA aims to improve consistency, traceability, and speed of preparation, it is not an official FDA tool. Any real-world submission must comply with current FDA guidelines and go through regulatory affairs review, with final validation conducted by qualified personnel.

See also: FDA, eCTD, regulatory informatics, RegTech, open-source software for life sciences.