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Record W2010584489 · doi:10.1136/bmj.g1845

US drug regulator rejects accusations that it unfairly targets Indian generic firms

2014· article· en· W2010584489 on OpenAlexaboutno aff
Sanjeet Bagcchi

Bibliographic record

VenueBMJ · 2014
Typearticle
Languageen
FieldEconomics, Econometrics and Finance
TopicEconomic Sanctions and International Relations
Canadian institutionsnot available
Fundersnot available
KeywordsRegulatorDrugInternet privacyComputer scienceBusinessMedicineLaw and economicsComputer securityPublic relationsData sciencePolitical sciencePharmacologyBiologyEconomicsGenetics

Abstract

fetched live from OpenAlex

The US drugs regulator has defended its actions against Indian generic drug manufacturers who flout safety and quality standards. The regulator said that product safety was its top priority and that it would take any action deemed necessary to protect consumers. Margaret Hamburg, the US Food and Drug Administration’s commissioner, was in India for a 10 day visit from 10 February. She angered some Indian officials, who claimed that the FDA was unduly targeting Indian companies for substandard practices. India supplies about 40% of the generic and over-the-counter drugs consumed in the United States, making it the second largest supplier (after Canada). But Indian drug manufacturers accounted for half of the warning letters issued by the FDA in 2013. In January the FDA banned the import of drugs made at two further facilities run by the Indian generics manufacturer Ranbaxy Laboratories after finding problems with the manufacturing …

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 distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesInsufficient payload (model declined to judge)
Consensus categoriesInsufficient payload (model declined to judge)
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.522
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0020.003

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 head0.040
GPT teacher head0.245
Teacher spread0.204 · 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; both teacher heads agree on what is shown here.

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

Citations0
Published2014
Admission routes1
Has abstractyes

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