StudentShare
Contact Us
Sign In / Sign Up for FREE
Search
Go to advanced search...
Free

FDA Authorization for the Next Generation Sequencer - Essay Example

Cite this document
Summary
An essay "FDA Authorization for the Next Generation Sequencer" reports that the genomic sequencer is to be applied in Pharmacogenomics by providing patients with specified prescriptions for drugs. Pharmacogenomics is one of the fields yet to be explored in clinical care…
Download full paper File format: .doc, available for editing
GRAB THE BEST PAPER91.7% of users find it useful
FDA Authorization for the Next Generation Sequencer
Read Text Preview

Extract of sample "FDA Authorization for the Next Generation Sequencer"

FDA Authorization for the Next Generation SequencerIn 2013, the USFDA granted marketing permits for a genomic sequencer, a technology set to revolutionize the healthcare system (Food and Drug Administration, 2013). Clinical care is expected to provide an individual based care system, based on the study of specific human genomes. In addition, the genomic sequencer is to be applied in Pharmacogenomics by providing patients with specified prescriptions to drugs. Pharmacogenomics is one of the fields yet to be explored in clinical care, and it is likely to enhance the quality of services by increasing the precision of predicting the outcomes of different dosages of drugs.

It is apparent that different people respond differently to different drugs, and the use of genome sequencing will not only reveal the nature and susceptibility of illnesses, but it will also provide physicians with the specific prescriptions required (Collins & Hamburg, 2013). This technology could be used to develop the most appropriate treatment combinations for different patients suffering from cancer. With genomic sequencing, it is possible for doctors to identify the nature of cancer and predict its spreading patterns; hence, the new system will be instrumental in helping doctors deal with different forms of cancer more appropriately (Collins & Hamburg, 2013).

Implementation Policy IssueThe authorization of marketing for the genomic sequencer is a step closer to developing clinical care that is individually oriented. It is; however, clear that some issues like the absence of legal and regulatory policies for the new system will arise (Collins & Hamburg, 2013). There are signs that the authorities are committed to developing the most conducive policies to enable the effective and ethical application of the genomic sequencer. The use of the genomics sequencing technology has the potential to attract ethical issues like insurance companies being acquainted with genomic information about their clients, which could cause the development of exempted services that might be discriminating (Collins & Hamburg, 2013).

Access to genomic information by physicians may also lead to substandard applications of the system. It is required that the development of accurate genomic information must be attained through thorough processes that may require recurrent experimentation (Collins & Hamburg, 2013). The FDA is collaborating with the National Institute for Standards and Technology to design the required interpretive material for physicians. The measure is applied to ensure that patients can discuss with the physicians about their health issues with reference to the genomic information that will be availed through the genomic sequencer.

It is, therefore, crucial that the FDA and the associated organizations develop policies that ensure safety is enhanced with the use of the genomic sequencer (Collins & Hamburg, 2013). RecommendationsThe first step should be ensuring that the application of the genomic sequencer has a set of guidelines that enhance the validity of the information. This should be closely tied with policies that enhance the safety of the system with relation to the development of personalized clinical services.

Patient information should also be safely possessed only by the relevant parties. For instance, insurance companies must only access such information with the consent of the patients to develop an insurance coverage system that suits the health requirements of the individuals. The cost of accessing the system should also be regulated for affordability purposes (NHGRI, 2014).ConclusionThe authorization to market the genomic sequencer is a positive move from the FDA into promoting the development of individual-based clinical care.

The system will possibly solve some of the challenges currently faced by health care providers. The recommended policies should be implemented to ensure legal and regulatory laws are observed in the use of the new system.ReferencesCollins, F.S., & Hamburg, M.A. (2013). First FDA authorization for next generation sequencer. NEJM, 369 (25), 2369-2371. FDA. (2013). FDA allows marketing of four “next generation” gene sequencing devices. Retrieved from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm375742.htmNHGRI. (2014).

DNA sequencing costs. Retrieved from: http://www.genome.gov/sequencingcosts/

Read More
Cite this document
  • APA
  • MLA
  • CHICAGO
(“FDA Authorization for the Next Generation Sequencer Essay”, n.d.)
FDA Authorization for the Next Generation Sequencer Essay. Retrieved from https://studentshare.org/health-sciences-medicine/1669790-write-a-presentation-about-the-first-fda-authorization-for-next-generation-sequencer-article-link-in-instructions-order
(FDA Authorization for the Next Generation Sequencer Essay)
FDA Authorization for the Next Generation Sequencer Essay. https://studentshare.org/health-sciences-medicine/1669790-write-a-presentation-about-the-first-fda-authorization-for-next-generation-sequencer-article-link-in-instructions-order.
“FDA Authorization for the Next Generation Sequencer Essay”, n.d. https://studentshare.org/health-sciences-medicine/1669790-write-a-presentation-about-the-first-fda-authorization-for-next-generation-sequencer-article-link-in-instructions-order.
  • Cited: 0 times

CHECK THESE SAMPLES OF FDA Authorization for the Next Generation Sequencer

Regulation: Case on Next Generation Broadband

The essay "Regulation: Case on next generation Broadband" emphasizes the aim of instituting regulation is to protect the interest of players in a given field.... For instance, the roll-out of the new generation broadband would influence internet service delivery and telecommunication services.... For instance, the roll-out of the new generation broadband would influence internet service delivery and telecommunication services.... However, new generation broadband technology is a new application in the market, which requires policies that would protect various interests....
6 Pages (1500 words) Essay

The Policy Enforcement Point, Secondary and Approximate Authorization Model

From the paper "The Policy Enforcement Point, Secondary and Approximate authorization Model " it is clear that the RBAC configurations are extracted as a result of an empirically validated approach that highlighted the performance of devices with low capability up to thousand access hits every second.... hellip; The development of a simulation testbed for evaluating the utility associated with SAAMBLP and utilizes it for developing a random test containing a set of authorization requests....
6 Pages (1500 words) Essay

Sequence Analysis

The paper "Sequence Analysis" discusses the dynamic programming of computer algorithms that become an essential tool in the era of the human genome and the need to explore the entire 3 billion DNA base pairs.... Words: 35 Characters: 208 … According to Giegerich, (2000), dynamic programming is the most popular programming method applied in bioinformatics....
7 Pages (1750 words) Lab Report

Next Generation Air Transportation System

the next generation Air Transport System program involves the use of Next Generation Air Transport System The need for faster and efficient movement has necessitated improvement of various transportation systems.... the next generation Air Transport System program involves the use of new technology to improve the services offered by the aviation sector.... ndoubtedly, the next generation Air Transportation System is a brilliant and useful program for the country's transport sector....
2 Pages (500 words) Essay

FDA Approval Procedure

The key objective at this point is to prove that the drug will not cause damage to humans in the next stage of the trials.... This discussion stresses that before a new remedy is introduced to the market, it undergoes a thorough and comprehensive approval process controlled by the fda.... fda Approval Procedure fda Approval Procedure Before a new remedy is introduced to the market, it undergoes a thorough andcomprehensive approval process controlled by the fda....
2 Pages (500 words) Assignment

FAAs Next Generation Air Transportation System

hellip; The object of this paper is next generation Air Transportation System (NextGen), a project of the Federal Aviation Administration (FAA).... This paper will discuss the FAA's NextGen project and some of its aspects on the American airspace and that of the world at large.... It will look at how NextGen hopes to operate, the deadline for implementation, challenges, criticism and some of its primary component....
11 Pages (2750 words) Research Paper

Next Generation Air Traffic Control

The following year in 2004, the department of transportation launched the integrated plan for the next generation Air Transportation system that showed the goals, objectives, and requirements that were necessary to come up with the NextGen System (Joint Planning and Development Office, 2007).... In the next month following it's signing the Department of Transport (DOT) secretary announced plans to develop an airport transportation system… The fourth system is the equipment that will be used in controlling aircraft at the airport especially on the runway before takeoff and after landing....
6 Pages (1500 words) Term Paper

Patient Participation Through Electronic Genomic Information

Having determined the initial costs of authenticating procedures and results of the Next-generation sequencer, it would be a waste of resources if the general public does not enjoy the benefits (Lefemine, 2012).... The Next-generation sequencer came after years of toil and expenditure estimated to be worth hundreds of millions of dollars (Collins & Hamburg, 2013).... The paper "Patient Participation Through Electronic Genomic Information" highlights that Next-generation Sequencing has ensured alternatives exist to unique medical cases and therefore physicians will have an easy time in terms of medical prescription....
6 Pages (1500 words) Essay
sponsored ads
We use cookies to create the best experience for you. Keep on browsing if you are OK with that, or find out how to manage cookies.
Contact Us