Search is Powered by Google
Regulatory Affairs / Drug Approvals News

Personalized Medicine Will Lead To Changes In FDA Approval Process For New Medications, Von Eschenbach Says

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 11 Nov 2008 - 8:00 PST

email icon email to a friend   printer icon printer friendly   write icon view / write opinions   rate icon rate article
Current Article Ratings:

Patient / Public:5 stars

5 (2 votes)

Health Professional:not yet rated

Article Opinions: 0 posts

Personalized medicine -- the ability to predict how patients will react to certain medications based on their genetic profiles -- will lead to changes in clinical trials and the business model for the pharmaceutical industry, as well as the FDA approval process for new treatments, agency commissioner Andrew von Eschenbach said on Friday during a speech to business students at St. Joseph's University, the Philadelphia Inquirer reports.

According to von Eschenbach, rather than focus on the positive and negative effects of new medications, trials in the future will seek to determine how medications work in the body and in patients with certain genetic profiles. He added that more cooperation will be needed among pharmaceutical, biotechnology and medical device companies in the future as a result of personalized medicine and that FDA will have to revise the agency approval process.

Von Eschenbach said, "The transformation is not a linear extrapolation of the past. It's a metamorphosis." The "future will look no more like the past than a butterfly looks like a caterpillar," he said. "Figuring out how to overhaul the drug approval process will fall to von Eschenbach's successor, to be appointed by President-elect Barack Obama," the Inquirer reports (Hill, Philadelphia Inquirer, 11/8).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation.  All rights reserved.




Customized Homepage Weekly Newsletters Daily News Alerts
Home About Us News Licensing Free Website Feeds Free Tools & Content Links Tell a Friend Accessibility Help / FAQ Article Submission Contact Us
Urology
ADHD Autism Diabetes

add medical news today to your facebook

medical news gadget

Add to Google


developers
website gadget code
website news code
medical news rss feed links


customize your homepage


These are the most read articles from this news category for the last 6 months:
Top Article Star
FDA To Recommend That Doctors Conduct Genetic Screening Before Prescribing Antiretroviral Abacavir To Reduce Allergic Reactions
25 Jul 2008
FDA on Thursday is expected to issue an advisory that urges physicians to conduct genetic testing before prescribing GlaxoSmithKline's antiretroviral drug abacavir to reduce allergic reactions in people taking the drug, the...


Weekend Athletes - Gearing Up for Outdoor Sports
Weekend Athletes - Gearing Up for Outdoor Sports

It's important for weekend athletes to make sure they prepare themselves for summer sports. Starting an exercise routine to get them ready for the game is a good idea. Weekend Athletes should also make sure they warm up before the game. You may also want to check the condition of your sneakers before you head out.

more videos are available in our health videos section.