| Title |
Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies
|
|---|---|
| Published in |
BMC Health Services Research, January 2013
|
| DOI | 10.1186/1472-6963-13-27 |
| Pubmed ID | |
| Authors |
Diane Nguyen, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Michael Montagne |
| Abstract |
The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Chile | 1 | 33% |
| Canada | 1 | 33% |
| United States | 1 | 33% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 3 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 27 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Jordan | 1 | 4% |
| Unknown | 26 | 96% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Doctoral Student | 5 | 19% |
| Student > Ph. D. Student | 4 | 15% |
| Researcher | 3 | 11% |
| Professor > Associate Professor | 3 | 11% |
| Student > Master | 3 | 11% |
| Other | 6 | 22% |
| Unknown | 3 | 11% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 6 | 22% |
| Business, Management and Accounting | 4 | 15% |
| Nursing and Health Professions | 3 | 11% |
| Social Sciences | 3 | 11% |
| Computer Science | 2 | 7% |
| Other | 6 | 22% |
| Unknown | 3 | 11% |
Attention Score in Context
This research output has an Altmetric Attention Score of 3. 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 24 May 2013.
All research outputs
#12,868,348
of 22,693,205 outputs
Outputs from BMC Health Services Research
#4,279
of 7,589 outputs
Outputs of similar age
#150,458
of 279,188 outputs
Outputs of similar age from BMC Health Services Research
#54
of 105 outputs
Altmetric has tracked 22,693,205 research outputs across all sources so far. This one is in the 42nd percentile – i.e., 42% of other outputs scored the same or lower than it.
So far Altmetric has tracked 7,589 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 7.6. This one is in the 42nd percentile – i.e., 42% of its peers scored the same or lower than it.
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 279,188 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 45th percentile – i.e., 45% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 105 others from the same source and published within six weeks on either side of this one. This one is in the 47th percentile – i.e., 47% of its contemporaries scored the same or lower than it.