NEWS
r4subprofile 0.3.0
- Add
compare_authorities(), a side-by-side comparison of submission profiles
across regulatory authorities: pillar weights, the SCI needed to be ready,
minimum coverage, the number of required indicators, and the detectability
default. A sponsor filing in more than one region can see how the readiness
bar changes between, say, the FDA and the EMA without building and reading
each profile by hand. Authority names match case-insensitively and the
submission type can be chosen per authority.
r4subprofile 0.2.0
- Add versioned rule packs:
rule_packs() lists the available packs,
rule_pack() selects one by id (for example "fda-2026.1") with an authority,
a version, and an effective date, rule_pack_indicators() returns its
indicators, and rule_pack_provenance() returns the identifying fields to
record on a scored result so a score can be traced to the exact ruleset that
produced it. Each indicator carries a source field for its authoritative
citation; the built-in packs ship these as NA (pending entry from a
controlled reference list rather than filled with unverified section numbers)
and they can be supplied through the sources argument.
r4subprofile 0.1.1
- Add vignette: "Regulatory Authority Profiles" covering
submission_profile(),
profile_summary(), validate_against_profile(), and authority weight comparisons.
r4subprofile 0.1.0 (2026-03-03)