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:5/26/2017)... ... May 26, 2017 , ... Rob Lowe acts as ... production of the series is on hiking in American. Viewers can reconnect with America ... great benefits of hiking. , Many consumers have looked for an inventive new place ...
(Date:5/26/2017)... ... ... FAMILY-Our Journey to the Cross”: the personal journey of Bob Massey and his faith in ... authors, Bob and Margaret Massey. Bob Massey is small in stature but big in ... His love for others is apparent in all of his life decisions. , ...
(Date:5/26/2017)... ... ... “Cactus Jack: Against All Odds”: the story of Coach Cactus Jack and the ... is the creation of published author, Walter Hubbard, a retired wildlife and fisheries biologist ... Jane. Walter. Walter and Jane have three adult children and a granddaughter. ...
(Date:5/24/2017)... ... May 24, 2017 , ... In ... choosing the most appropriate instruments for research and understanding the basic principles that ... webinar will focus on innovations in stereo microscopy for brightfield and fluorescence typically ...
(Date:5/24/2017)... ... May 24, 2017 , ... NucleusHealth ™, ... has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ... secure cloud platform for medical image management. At the core is patented streaming ...
Breaking Medicine News(10 mins):
(Date:5/9/2017)... , May 9, 2017 Zimmer Biomet Holdings, ... musculoskeletal healthcare, today announced it has earned a spot ... 2017" list. The Company was ranked among 500 U.S. ... Employers and Healthcare Equipment and Services. The ... on an anonymous, independent survey of over 30,000 employees ...
(Date:5/9/2017)... 2017  Oramed Pharmaceuticals Inc. (NASDAQ: ... company focused on the development of oral drug ... Property Office has granted Oramed a patent titled, ... The patent covers Oramed,s invention of an oral ... an incretin hormone that stimulates the secretion of ...
(Date:5/8/2017)... NEW YORK , May 8, 2017 ... in the transition from fee for service reimbursement. Black ... April 2017. 1.       The Market for ... 77% of physician practices with 3 or ... Compliance Technology Solutions by Q4. "Given the magnitude of ...
Breaking Medicine Technology: