| Title |
Recent updates and challenges on the regulation of precision medicine: The United States in perspective
|
|---|---|
| Published in |
Regulatory Toxicology & Pharmacology: RTP, April 2018
|
| DOI | 10.1016/j.yrtph.2018.04.021 |
| Pubmed ID | |
| Authors |
Lin-Chau Chang, Thomas E. Colonna |
| Abstract |
The rapid progress in "omics", such as genomics, metabolomics, microbiomics, has paved the path for precision medicine and revolutionized the development of drugs and devices promising to meet unmet medical needs. The aim of the present study was to investigate the current regulatory framework established by the United States Food and Drug Administration (USFDA) and to identify challenges and concerns through study of related literatures in the PubMed database. We found that efforts were made to facilitate the implementation of precision medicine through organizational reform, publication of guidance documents, and continuous post-market surveillance. The challenges identified included the critical, fundamental structural requirements of databases, essential regulatory considerations for market approval, and the appropriate clinical use such as whole genomic sequencing tests especially for a newborn or even fetus. These issues are worth further research to devise an integral approach involving scientific, ethical, legal, and social considerations. |
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 % |
|---|---|---|
| United States | 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 66 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 66 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 12 | 18% |
| Other | 7 | 11% |
| Student > Master | 7 | 11% |
| Student > Ph. D. Student | 7 | 11% |
| Student > Bachelor | 5 | 8% |
| Other | 6 | 9% |
| Unknown | 22 | 33% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 11 | 17% |
| Agricultural and Biological Sciences | 4 | 6% |
| Biochemistry, Genetics and Molecular Biology | 4 | 6% |
| Social Sciences | 3 | 5% |
| Engineering | 3 | 5% |
| Other | 18 | 27% |
| Unknown | 23 | 35% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. 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 2018.
All research outputs
#22,767,715
of 25,382,440 outputs
Outputs from Regulatory Toxicology & Pharmacology: RTP
#2,007
of 2,142 outputs
Outputs of similar age
#298,329
of 338,552 outputs
Outputs of similar age from Regulatory Toxicology & Pharmacology: RTP
#30
of 34 outputs
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So far Altmetric has tracked 2,142 research outputs from this source. They typically receive more attention than average, with a mean Attention Score of 9.0. This one is in the 1st percentile – i.e., 1% of its peers scored the same or lower than it.
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We're also able to compare this research output to 34 others from the same source and published within six weeks on either side of this one. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.