Navigation Links
Advent of New, More Effective and Personalized Medicines

The FDA today issued a final guidance titled "Pharmacogenomic Data Submissions" to speed// development of new medical products through the science of pharmacogenomics.

Pharmacogenomics allows health care providers to identify sources of an individual's profile of drug response and predict the best possible treatment option for this individual. This technology has enabled the development of targeted therapies like Herceptin for metastatic breast cancer, Gleevec for chronic myeloid leukemia and Erbitux for metastatic colorectal cancer.

This new approach will allow medicines to be uniquely crafted to maximize their therapeutic benefits and minimize the potential risks for each patient. Doctors will eventually be able to analyze a patient's genetic profile and prescribe the best available drug therapy and dose from the start.

FDA also approved the first laboratory test, the Amplichip Cytochrome P450 Genotyping Test, which will enable physicians to use genetic information to select the right doses of certain medications for cardiac, psychiatric diseases and cancer.

The final guidance describes what data will be needed during the marketing application review process, the format for submissions, and the data that will be used during regulatory decision-making. The guidance also explains a new mechanism for industry to voluntarily submit research data to further the scientific exchange of information as we move into more advanced areas of pharmacogenomic research.

The voluntary data, will be reviewed by an internal, agency-wide group and will not be used for regulatory decision making, but will help FDA and industry gain valuable experience. FDA believes this approach will save time and resources and eliminate possible delays in the application review process.

FDA has already received several pharmacogenomic data submissions through both the regulatory and voluntary processes and will continue to work cl osely with industry and the healthcare community.

In addition to announcing the availability of its final guidance and the new pharmacogenomic Web page, the agency also reminded the public of the meeting being held on pharmacogenomics issues.

The joint FDA/DIA meeting, "Pharmacogenomics in Drug Development and Regulatory Decision Making” will focus on integrating pharmacogenomics in clinical trials for new drugs, biologics, and associated devices. FDA will also address ways to translate pharmacogenomics into medical product development and clinical practice.


'"/>




Related medicine news :

1. Adventure Enthusiasts, Risk Takers and Those Living on the Edge, Good News Coming Your Way
2. Adrenaline Associated With Adventurers Risk Taking
3. New Way to "See" Genes, Evaluate Effectiveness of Gene Therapies Discovered
4. Inhaled Steroids Safe & Effective for Children with Asthma
5. ZD1839 Proves Effective - A Breakthrough in fighting Lung Cancer
6. Fluoride Found Effective in Osteoporosis
7. Aspirin and Warfarin Are Equally Effective for Stroke Prevention
8. Implantable Contact Lens Found Safe and Effective
9. Effective And Economical Agent For Anthrax
10. Stem Cell Transplants May Be Effective For MS Patients
11. Effective therapy for Huntingtons disease
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:2/8/2016)... Los Angeles, CA (PRWEB) , ... February 08, 2016 , ... ... autism conference held annually in this country. The AutismOne 2016 Conference, which is being ... the truth they often won’t hear elsewhere about helpful interventions and causes of chronic ...
(Date:2/7/2016)... ... February 07, 2016 , ... ... MyDecision™ empowers employers and organizations with the tools and information to lower the ... elements to cut the cost of providing employee healthcare benefits by as much ...
(Date:2/6/2016)... ... February 06, 2016 , ... With the FCPX LUT: Summer ... grades to their footage. A LUT is a Lookup Table that contains a mathematical ... color indicated by the table. By manipulating each pixel, LUT's can change each color ...
(Date:2/5/2016)... ... February 05, 2016 , ... Love is in the air at King Kullen! ... assortments and packaging. This staple for Valentine’s Day is a must-have, and can be ... Valentine’s Day, not only are long-stem roses available, but also other flower bouquets, elegantly ...
(Date:2/5/2016)... ... 2016 , ... The event is being held on April 7, 2016 from ... Triumph Over Parkinson’s will fund nearly $100,000 for research for the care and cure ... disease and is the architect of this informative event to raise awareness and funds ...
Breaking Medicine News(10 mins):
(Date:2/4/2016)... , Feb. 4, 2016 Summary Breast ... cancer and the most common cancer in women worldwide, ... disease exceedingly prevalent. The number of women diagnosed with ... but the number of deaths has declined due to ... treatment has been revolutionized in the past four decades, ...
(Date:2/4/2016)... VIEW, Calif., Feb. 4, 2016  Omnicell, Inc. (NASDAQ: ... management solutions to healthcare systems, today announced results for ... --> --> GAAP ... $130.3 million, up $5.1 million or 4.1% from the ... 7.2% from the fourth quarter of 2014. Revenue for ...
(Date:2/4/2016)... 4, 2016 In response to the opioid abuse ... Commissioner for Medical Products and Tobacco, along with other FDA ... agency,s approach to opioid medications. The plan will focus on ... in pain access to effective relief. ... , Re-examine the risk-benefit paradigm for opioids and ensure that ...
Breaking Medicine Technology: