An open working space for people who want neonates, infants, children, and adolescents to be included earlier in research and in regulatory decisions, across common and rare disease. It gathers the rules, ethics frameworks, agency meeting routes, data sources, methods, organizations, and funders into one staged catalog, and it gives any group of organizations a repeatable way to find, triage, draft, and file public comments together.
The staged catalog: a regulatory roadmap in the order a team meets the questions, ethics and Institutional Review Board (IRB) frameworks, agency interaction routes, pediatric data sources, standards and methods, a live literature search, organizations, funders, a map, a coverage view, and a shortlist that downloads.
Open the landscapeA generic process for responding to requests for comment and requests for information from the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and other agencies: find open comment periods, record the decision to respond, split a notice into questions, collect positions from each organization, draft, review, sign, submit, and archive.
Open the Comment DeskInclusion policies, age categories, and the guidance that supports enrolling adolescents in adult trials or lowering a minimum age.
Regulatory roadmapSubpart D risk categories, assent and permission, neonatal provisions, international codes, and practical aids for a pediatric protocol.
Ethics and IRBMeeting types, listening sessions, advisory committees, public dockets, and the offices that handle pediatric and rare disease questions.
Agency interactionEntries tagged for neonates across regulation, ethics, data sources, consortia, and funders.
Neonates across the catalogIncentives, evidence approaches for small populations, natural history and registry sources, and rare disease organizations.
Rare disease across the catalogAdvocacy groups, professional societies, research networks, and coalitions, with a map and a coverage view that shows where the catalog is thin.
OrganizationsBuild a query from population and theme lenses, run it live against Europe PMC, and open the same query in PubMed.
LiteratureSearch the Federal Register for open comment periods, add a notice to the docket register, and start a shared comment.
Find and ingest a noticeThe site is a plain set of static pages served by GitHub Pages, so a coalition, a working group, or a single organization can fork it, rename it, and run its own copy. The catalog lives in one JavaScript file per kind of record under assets/js/landscape/, and a correction is a one-line edit proposed through a pull request or an issue form. The Comment Desk runs entirely in the browser and keeps work in a save file that reloads, and the comments/ folder gives each comment opportunity a dated folder with the notice, the question breakdown, positions, the draft, signatories, and the submission record.
Draft comments kept in a public repository are public. A group that wants to draft privately can keep the Comment Desk save file on a shared drive, or run a private copy of the repository, and publish the final comment to the archive after it is filed. The README explains both arrangements.
Related free browser tools, including ones for literature search, engagement, registries, and governance, are on the Boyce Data Science free tools page.
Entries in the catalog are a snapshot dated on the landscape page. Each entry says whether its link and status were checked for the snapshot, and the Method and sources stage lists the web sites used.