Navigation Links
Companion Diagnostics in Personalized Medicine and Cancer Therapy
Date:8/6/2014

/>Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions 265
Appendix 1.1: Introduction 265
Appendix 1.2: Background 265
Appendix 1.3: Submission Policy 266
Appendix 1.3.1: General Principles 266
Appendix 1.3.2: Specific Uses of Pharmacogenomic Data in Drug Development and Labeling 268
Appendix 1.3.3: Benefits of Voluntary Submissions to Sponsors and FDA 269
Appendix 1.4: Submission of Pharmacogenomic Data 269
Appendix 1.4.1: Submission of Pharmacogenomic Data During the IND Phase 270
Appendix 1.4.2: Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement 271
Appendix 1.4.3: Submission to a Previously Approved NDA or BLA 272
Appendix 1.4.4: Compliance with 21 CFR Part 58 272
Appendix 1.4.5: Submission of Voluntary Genomic Data from Application-Independent Research 272
Appendix 1.5: Format and Content of a VGDS 273
Appendix 1.6: Process for Submitting Pharmacogenomic Data 274
Appendix 1.7: Agency Review of VGDSs 274
Appendix 2: FDA Issues Draft Companion Diagnostic Guidance 276
Appendix 3: Histochemical Markers for Cancer 278
Appendix 4: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions 279

Appendix 4.1: Introduction 279
Appendix 4.2: Background 279
Appendix 4.3: Scope 279
Appendix 4.4: General Principles 279
Appendix 4.5: Structure of Biomarker Qualification Submissions 280
Appendix 5: Selected Personalized Medicine Drugs, Treatments and Diagnostics as of June 2014 287
Glossary 292


INDEX OF FIGURES

Figure 2.1: Strategic and Tactical Considerations for Co-Development of Companion Diagnostics 24
Figure 2.2: Global Market for Companion Diagnostics, 2012-2019 25
Figure 2.3: Number of Companion Diagnostic Agreements, 2000-2013 26
Figure 2.4: Surface Binding Produces Phase Shifts that Increases the Diffraction Signal Intensity 36'/>"/>

SOURCE ReportBuyer
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related medicine technology :

1. Ventana paves the way for companion diagnostic early phase clinical trials in China to advance patient care
2. QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients
3. Ventana Medical Systems, Inc. and Merck KGaA, Darmstadt, Germany to develop companion diagnostic test for cancer treatment
4. Ventana announces HER2 companion diagnostic to identify breast cancer patients for Roches latest targeted medicines, Perjeta and Kadcyla
5. Ventana to partner with Incyte on the development of Companion Diagnostic tests
6. Kennel Cough is in Season all Year for our Canine Companions
7. Harrisvaccines, Inc. Secures Exclusive Rights From AlphaVax, Inc. to Develop RNA Particle Vaccines for All Diseases in Companion Animals
8. Ventana receives approval from Chinas FDA for first fully automated IHC companion diagnostic identifying ALK protein expression in lung cancer patients
9. Companion Diagnostics Market Report - Streamlining Drug Development and Advancing Personalized Medicine
10. Companion Diagnostics Market, 2012-2023
11. Companion 2 Hospital Driver for Powering SynCardia Total Artificial Heart Wins Silver at Medical Design Excellence Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... , Aug. 27, 2015  Eli Lilly and Company ... Global Healthcare Conference on Thursday, September 17, 2015. ... of Lilly Oncology and Richard Gaynor , M.D., ... for Lilly Oncology, will participate in a fireside chat ... A live audio webcast will be available on the ...
(Date:8/27/2015)... , Aug. 27, 2015   Women Grow , the fastest-growing ... is partnering with the Cannabis World Congress & Business ... to produce 15 business-focused educational sessions. CWCBExpo in LA will ... Angeles Convention Center in Los Angeles, ... the West Coast for the marijuana industry. The ...
(Date:8/27/2015)... Aug. 27, 2015  MiMedx Group, Inc. (NASDAQ: ... human amniotic tissue and patent-protected processes to develop ... Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic ... corrected the multiple inaccuracies in the press release ... the recent rulings from the Patent Trial and ...
Breaking Medicine Technology:Lilly to Participate in Morgan Stanley Global Healthcare Conference 2Cannabis World Congress in Los Angeles Boasts Women Grow Sponsored Education 2Cannabis World Congress in Los Angeles Boasts Women Grow Sponsored Education 3Cannabis World Congress in Los Angeles Boasts Women Grow Sponsored Education 4MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 2MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 3MiMedx Corrects Inaccuracies In MTF Press Release Regarding The Recent Rulings From The Patent Trial And Appeal Board 4
... 2011 Boston Scientific Corporation (NYSE: BSX ) ... to fund the "Donald S. Baim, M.D., ,75 Scholarship Fund" ... the late interventional cardiology pioneer and Yale School of Medicine ... Officer from 2006 until 2009, when he died unexpectedly. ...
... Calif., Feb. 15, 2011 Viral Genetics, Inc. (Pink Sheets: ... M. Karen Newell Rogers and Advisor Mr. Richard Gerstner will ... for Lyme, Inc. The award presentation is set for the ... Dr. Newell Rogers is being recognized for her research on ...
Cached Medicine Technology:Boston Scientific Establishes Endowment for Donald S. Baim, M.D., Scholarship at Yale School of Medicine 2Boston Scientific Establishes Endowment for Donald S. Baim, M.D., Scholarship at Yale School of Medicine 3Boston Scientific Establishes Endowment for Donald S. Baim, M.D., Scholarship at Yale School of Medicine 4Viral Genetics' Researcher and Advisor Set to Share Award 2Viral Genetics' Researcher and Advisor Set to Share Award 3
(Date:8/29/2015)... ... August 29, 2015 , ... People ... pulmonary disease (including emphysema), or asthma, are at higher risk from wildfire smoke ... attack, heart failure or heart-rhythm problems (arrhythmia or irregular heartbeat) are also sensitive ...
(Date:8/29/2015)... ... , ... The popular television program VOICES IN AMERICA, hosted by legendary star ... devoting an entire short segment to the subject of diabetes. Diabetes is a debilitating ... daily basis, but recent advancements in medical science may prove to be a significant ...
(Date:8/28/2015)... ... ... Rio Salado College joined nine educational institutions in Washington D.C., ... EDUCAUSE - Next Generation Learning Challenges 2015 Breakthrough Models Incubator funded by the ... Incubator hosted by EDUCAUSE and NGLC, which is designed to bring leadership teams ...
(Date:8/28/2015)... ... August 28, 2015 , ... An online provider of ... make the purchase of CPAP equipment more affordable by offering shipping at no cost ... of CPAP products and orders of any size. My Cpap Store is located in ...
(Date:8/28/2015)... ... August 28, 2015 , ... The Kentucky State Department of Workforce Investment Commissioner ... they are applying for, they are unable to pass the initial drug test and ... testing policies in order to be able to hire long-term, skilled talent. (1) Will ...
Breaking Medicine News(10 mins):Health News:Heart Fit Clinic Sounds the Alarm on Forest Fire Smoke and Chronic Heart Disease in Calgary Area 2Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 2Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 3Health News:Rio Salado College Joins 9 Educational Leaders to Reinvent Higher Learning 4Health News:My Cpap Store Now Offering Delivery Special 0 Cost to You 2Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 2Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 3Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 4
... It,s National Nutrition Month(R) and Cabot Creamery Cooperative ... Year-Round HealthCABOT, Vt., March 6 March is ... Dietetic Association,s campaign designed to focus attention on ... developing sound eating and physical activity habits, Cabot ...
... Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL ... vice president and chief financial officer, is scheduled ... Capital Healthcare Conference in Miami, Florida on Tuesday, ... http://www.newscom.com/cgi-bin/prnh/20030226/RIGLLOGO )To access the live audio webcast or ...
... by the U.S. Supreme Court will protect the rights of consumers who ... “The Supreme Court’s ruling this week is an important victory for plaintiffs ... Kientz. , ... Austin, TX (Vocus) March 6, 2009 -- A ruling ...
... direct-to-traveler oxygen services for airlines and individuals, today announced it is ... commercial flights originating or departing from a U.S. airport allow passengers ... aircraft. The U.S. Department of Transportation regulation (14 CFR 382 published ... , ...
... Wis., March 5 For Shannon Kenitz of Madison, Wisconsin, ... annual Road Warrior contest has meant hope for a ... the mother of a special needs child herself, and she,s ... bonus points and one million American Airlines AAdvantage miles to ...
... exercise equals that of stopping smoking, experts say, , , THURSDAY, ... they are 50 can extend their life span by more ... found that exercising has the same beneficial effect on length ... almost half of middle-age men don,t exercise, the researchers said. ...
Cached Medicine News:Health News:Photo: March Forth Into Spring with a Healthy Approach to Diet and Exercise 2Health News:Photo: March Forth Into Spring with a Healthy Approach to Diet and Exercise 3Health News:Photo: March Forth Into Spring with a Healthy Approach to Diet and Exercise 4Health News:Supreme Court Ruling is a Victory for Consumers Injured by Dangerous Drugs, Says Hissey Kientz, LLP 2Health News:Supreme Court Ruling is a Victory for Consumers Injured by Dangerous Drugs, Says Hissey Kientz, LLP 3Health News:OxygenToGo Is Poised To Help Airlines Struggling With New Portable Oxygen Concentrator Regulations From The U.S. DOT 2Health News:OxygenToGo Is Poised To Help Airlines Struggling With New Portable Oxygen Concentrator Regulations From The U.S. DOT 3Health News:Mother of Sick Child Donates Millions to Children 2Health News:Men Who Get Active in Midlife Live Longer 2Health News:Men Who Get Active in Midlife Live Longer 3
Convenience, Protection, Comfort and Security -- FirstChoice pouches are your product of choice if you are looking for the convenience of a one-piece pouch that is either cut-to-fit or pre-cut to you...
Inquire...
Superior comfort and flexibility are achieved through the revolutionary air pocket technology in the dimpled, ultra-thin SoftFlex skin barrier along with a discreet pouch shape and size....
Inquire...
Medicine Products: