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Record W1463745293 · doi:10.24926/15529541.3697

Can Regulation be as Innovative as Science and Technology? The FDA's Regulation of Combination Products

2005· article· en· W1463745293 on OpenAlexaff
Susan Bartlett Foote, Robert J. Berlin

Bibliographic record

VenueMinnesota journal of law, science & technology · 2005
Typearticle
Languageen
FieldMedicine
TopicBiomedical Ethics and Regulation
Canadian institutionsInstitute of Health Services and Policy Research
Fundersnot available
KeywordsFood and drug administrationRegulatory scienceLegislatureVariety (cybernetics)Engineering ethicsBusinessProduct (mathematics)Regulatory affairsRisk analysis (engineering)Gene technologyMedicineBiotechnologyEngineeringPolitical scienceComputer scienceLawBiology

Abstract

fetched live from OpenAlex

codified as amended at 42 U

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.029
metaresearch head score (Gemma)0.063
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesScience and technology studies
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: none
Teacher disagreement score0.995
Threshold uncertainty score0.152

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0290.063
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0010.001
Bibliometrics0.0010.001
Science and technology studies0.0050.030
Scholarly communication0.0140.020
Open science0.0020.005
Research integrity0.0290.015
Insufficient payload (model declined to judge)0.0070.002

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.015
GPT teacher head0.298
Teacher spread0.283 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

Study designNot applicable
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations29
Published2005
Admission routes1
Has abstractyes

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