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X Demographics
Mendeley readers
Attention Score in Context
| Title |
FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines
|
|---|---|
| Published in |
Frontiers in Pharmacology, April 2017
|
| DOI | 10.3389/fphar.2017.00161 |
| Pubmed ID | |
| Authors |
Lawrence Liberti, Magda Bujar, Alasdair Breckenridge, Jarno Hoekman, Neil McAuslane, Pieter Stolk, Hubert Leufkens |
| Abstract |
The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR), and Accelerated Approval (AA). Only PR specifies an expedited review timeline (6 months). We sought to determine to what extent the combination of two or more FRPs influenced development and approval times. We developed a "metro map" to illustrate FRP elements and their influence on review times. We assessed 125 new active substances (approved January 2013 to December 2015) 74 of which used one or more FRPs. For these 74, development times ranged from 1,458 (BTD + PR + AA) to 3,515 days (PR). PR alone had a median approval time of 242 days. The most common combination was FT + PR (median approval 292 days, n = 21). The fastest approval times were for PR + FT + BTD + AA (145 days) and PR + BTD + AA (166 days). Our findings support the combination of FRPs for shortening development and review times beyond that provided by PR alone. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Switzerland | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 32 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 32 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Ph. D. Student | 6 | 19% |
| Other | 5 | 16% |
| Researcher | 4 | 13% |
| Student > Doctoral Student | 2 | 6% |
| Student > Bachelor | 1 | 3% |
| Other | 3 | 9% |
| Unknown | 11 | 34% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 7 | 22% |
| Pharmacology, Toxicology and Pharmaceutical Science | 4 | 13% |
| Social Sciences | 3 | 9% |
| Unspecified | 1 | 3% |
| Biochemistry, Genetics and Molecular Biology | 1 | 3% |
| Other | 5 | 16% |
| Unknown | 11 | 34% |
Attention Score in Context
This research output has an Altmetric Attention Score of 10. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 29 May 2022.
All research outputs
#3,397,212
of 24,226,848 outputs
Outputs from Frontiers in Pharmacology
#1,560
of 18,093 outputs
Outputs of similar age
#61,341
of 312,791 outputs
Outputs of similar age from Frontiers in Pharmacology
#24
of 202 outputs
Altmetric has tracked 24,226,848 research outputs across all sources so far. Compared to these this one has done well and is in the 85th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 18,093 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.2. This one has done particularly well, scoring higher than 90% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 312,791 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 80% of its contemporaries.
We're also able to compare this research output to 202 others from the same source and published within six weeks on either side of this one. This one has done well, scoring higher than 87% of its contemporaries.