Evidence map›Paper›PMID 29443198›Full record

ArticleNeurology. Clinical practice2015

The US Food and Drug Administration, neurologists, and drug development and regulation.

Gerald J Dal Pan

Abstract read
In one paragraph

Article in Neurology. Clinical practice, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Gerald J Dal PanOffice of Surveillance and Epidemiology, US Food and Drug Administration, Silver Spring, MD.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The US Food and Drug Administration (FDA) plays a vital role in the regulation of human drugs and therapeutic biologics. Most physicians, while aware of the broad reach of the FDA, are unaware of what the agency actually does and how it does it. Practicing neurologists should be aware of the role neurologists can play in drug development, the informational resources that the FDA provides to practitioners, and the process of submitting reports of suspected adverse drug reactions to the FDA.

Identifiers

PMID29443198
PMCPMC5764476

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.