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:10/13/2017)... ... October 13, 2017 , ... Dickinson Insurance ... insurance and financial preparation services, is providing an update on a charitable event ... Rock City Rescue is a locally recognized nonprofit that provides shelter and care ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The American Board ... become its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon ... beginning July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon ...
(Date:10/13/2017)... (PRWEB) , ... October 13, ... ... School of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, ... professionals on guideline updates for the primary prevention of cardiovascular diseases during ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out ... free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting ... children of all ages; it is a non-competitive, non-timed event, which is all about ...
Breaking Medicine News(10 mins):
(Date:9/22/2017)... , Sept. 22, 2017 AVACEN Medical (AVACEN) ... is now successfully helping those with the widespread pain ... Fibromyalgia diagnosed Amanda in Essex, England ... washing my hair, experiencing no sleep at all, tremendous ... spasm… I cannot recommend [the AVACEN 100] enough, how ...
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , Sept. ... Penn. , and OptiMed Specialty Pharmacy of ... partnership to offer a strategic hub service that expedites ... highly sought-after personal spirometer, Spiro PD 2.0, and wellness ... A spirometer is a medical device used to measure ...
(Date:9/12/2017)... and NEW YORK , Sept. 12, 2017 ... performance ratings for global supply chains, has published the first annual edition ... CSR performance of more than 20,400 companies evaluated by EcoVadis, based on ... 2015 and 2016. ... EcoVadis Global CSR Risk & Performance Index ...
Breaking Medicine Technology: