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
'"/>




Page: 1 2

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:
TAG: Advent New More Effective and Personalized Medicines

(Date:9/16/2014)... who tend to be on the heavy side. Researchers ... found that seven in every ten obese adults underestimate ... this mistake much less often. Mothers of overweight or ... as youngsters misjudge their obese mothers, size, says lead ... a study in the Journal of General Internal ...
(Date:9/16/2014)... the unwitting focus of some of Australia,s best fast ... their performance in competition, thanks to a new training ... Greenwood, from QUT,s Institute of Health and Biomedical Innovation, ... of Excellence for Applied Sport Science Research, has studied ... cricket, long jump, triple jump and pole vault and ...
(Date:9/16/2014)... that compared patient-reported outcomes of a broad set ... single fraction radiation therapy (SFRT) is equally as ... pain, function and quality of life are considered, ... Society for Radiation Oncology,s (ASTRO,s) 56th Annual Meeting. ... pain, function and degree of distress were similar ...
(Date:9/16/2014)... For patients with locally advanced pancreatic cancer, the ... may be a promising treatment option, ultimately allowing ... be an option, according to research presented today ... 56th Annual Meeting. , Surgery is the only ... adenocarcinoma (PDA), the most common type of pancreatic ...
(Date:9/16/2014)... 2014 -- While abnormalities in the adrenergic and ... are thought to play a role in the ... there has been no genetic evidence of this ... at Columbia University,s Mailman School of Public Health ... between the ADRB2 gene and childhood adversity. For ...
Breaking Medicine News(10 mins):Health News:Poor body size judgement can lead to increased tolerance of obesity 2Health News:Getting the jump on competitors: QUT study 2Health News:Single fraction RT as effective as multiple fraction RT for bone metastases 2Health News:Single fraction RT as effective as multiple fraction RT for bone metastases 3Health News:Single fraction RT as effective as multiple fraction RT for bone metastases 4Health News:Chemotherapy and SABR consecutively may be promising treatment option for advanced pancreatic cancer 2Health News:Chemotherapy and SABR consecutively may be promising treatment option for advanced pancreatic cancer 3Health News:Chemotherapy and SABR consecutively may be promising treatment option for advanced pancreatic cancer 4Health News:Evidence of genetic link to PTSD in soldiers exposed to childhood trauma 2Health News:Evidence of genetic link to PTSD in soldiers exposed to childhood trauma 3
... heart attack and stroke, U.S. officials say , , ... Prilosec with the popular blood thinner Plavix (clopidogrel) can ... at risk for heart attack or stroke, U.S. health ... recently submitted studies by the manufacturer of clopidogrel [Sanofi-Aventis ...
... Seattle Sutton,s Healthy Eating (SSHE) and the ... MCHC affiliated members with meal discounts for SSHE. , ... than 140 hospitals and health care organizations dedicated to improving ... care and in assisting its members in improving the delivery ...
... Mo. Until recently, scientists believed that, following a ... any lost function. After that, patients would be forced ... their remaining abilities. Although this belief has been refuted, ... the current health system is still not giving patients ...
... 17 As we approach Thanksgiving, "Black Friday" and the ... community to please remember the children and families whose lives ... recovery and survival. Among these diseases are leukemia and ... disease, hemophilia and other diseases. , Please take a few ...
... VEGAS, Nov. 17 Ultimat Vodka has recently announced plans ... eliminating world hunger, to help raise awareness and funds for ... "I,m Tired of...," (ITo) Ultimat has created unique wrist ... message "I,m Tired of Hunger." For each bracelet produced, Ultimat ...
... surgery, gunshot victim continues to show improvement , TUESDAY, ... the first facial transplant in the United States can ... her nose, according to a report from her surgeons. ... from the transplanted tissue have integrated with existing tissue, ...
Cached Medicine News:Health News:Heartburn Drugs Can Thwart Popular Blood Thinner 2Health News:Seattle Sutton's Healthy Eating Partners With Metropolitan Chicago Healthcare Council to Provide Discounts for Hospital Patients and Employees 2Health News:Seattle Sutton's Healthy Eating Partners With Metropolitan Chicago Healthcare Council to Provide Discounts for Hospital Patients and Employees 3Health News:Pushing the brain to find new pathways 2Health News:These Patients Need Your Help This Thanksgiving 2Health News:These Patients Need Your Help This Thanksgiving 3Health News:Ultimat Vodka Joins Fight Against Hunger 2Health News:Face Transplant Patient Can Smell, Taste, Breathe Normally 2Health News:Face Transplant Patient Can Smell, Taste, Breathe Normally 3
(Date:9/16/2014)... -- Northwest Biotherapeutics (NASDAQ: NWBO ) ("NW ... for solid tumor cancers, announced today that its DCVax-L ... a "Promising Innovative Medicine" (PIM) under the new "Early ... in April 2014.  A PIM is the first step ... the EAMS.  The PIM designation for ...
(Date:9/16/2014)... OKLAHOMA CITY , Sept. 16, 2014 ... biopharmaceutical company developing novel orally active drugs ... existing antibiotics, announced today a $1.4 million ... investing arm of life sciences accelerator Accele ... from i2E, Inc., a nationally recognized private ...
(Date:9/16/2014)... CALGARY, Alberta , Sept. 16, 2014 /PRNewswire/ ... $1.4 billion industry in less than two years, ... along the way. A huge opportunity exists for ... Today, Vivametrica ( http://vivametrica.com/our-video/ ) introduced a first-of-its-kind ... providers based on years of clinical research linking ...
Breaking Medicine Technology:NW BIO'S CANCER VACCINE IS THE FIRST DRUG TO BE DESIGNATED BY UK AUTHORITIES AS A "PROMISING INNOVATIVE MEDICINE" (PIM) 2NW BIO'S CANCER VACCINE IS THE FIRST DRUG TO BE DESIGNATED BY UK AUTHORITIES AS A "PROMISING INNOVATIVE MEDICINE" (PIM) 3NW BIO'S CANCER VACCINE IS THE FIRST DRUG TO BE DESIGNATED BY UK AUTHORITIES AS A "PROMISING INNOVATIVE MEDICINE" (PIM) 4NW BIO'S CANCER VACCINE IS THE FIRST DRUG TO BE DESIGNATED BY UK AUTHORITIES AS A "PROMISING INNOVATIVE MEDICINE" (PIM) 5Synereca Pharmaceuticals Announces Financing Led by Accele Venture Partners 2Synereca Pharmaceuticals Announces Financing Led by Accele Venture Partners 3Synereca Pharmaceuticals Announces Financing Led by Accele Venture Partners 4Doctors Launch Initiative to Bridge Gap Between Wearables and Meaningful Health Data 2Doctors Launch Initiative to Bridge Gap Between Wearables and Meaningful Health Data 3
... DIEGO, June 10, 2011 Volcano Corporation (NASDAQ: ... precision intravascular diagnosis and therapy guidance tools designed to ... said today that it will be participating in the ... on Thursday, June 16. The presentation by ...
... Accuray Incorporated (Nasdaq: ARAY ), a global leader ... have approved the proposed acquisition of TomoTherapy Incorporated (Nasdaq: ... 98 percent of votes cast and 79 percent of shares ... anticipate the closing of the transaction will occur within one ...
Cached Medicine Technology:TomoTherapy Shareholders Approve Accuray Acquisition of TomoTherapy 2TomoTherapy Shareholders Approve Accuray Acquisition of TomoTherapy 3TomoTherapy Shareholders Approve Accuray Acquisition of TomoTherapy 4
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: