BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Camargo Pharmaceutical Services Celebrates Two 10-Year Anniversaries at Drug Information Association


6/4/2013 10:04:37 AM

Staying up-to-date has never been simpler. Sign up for the free GenePool newsletter today!

(Cincinnati, OH; June 4, 2013) – The U.S. regulatory landscape has changed dramatically in 10 years. In 2003, the FDA finally resolved legal hurdles to the 505(b)(2) approval pathway, making it a practical alternative route for drug development. The same year, Ken Phelps and Ruth Stevens founded Camargo Pharmaceutical Services to help companies gain approval under 505(b)(2).

The Camargo team will be celebrating both events in booth #410 at the Drug Information Association (DIA) Annual Meeting in Boston, June 23-27.

“FDA approvals under 505(b)(2) have risen every year since 2003 because it offers a faster and less costly process that permits developers to minimize risk and often still receive patent protection,” Phelps said. “2012 was another record year, with 47 505(b)(2) drug approvals in all, 50 percent more than the number approved under 505(b)(1).”

Typically, a new drug application approved under the standard 505(b)(1) regulatory path will take as much as 15 years and a nine-figure investment to work its way through the system. However, drugs approved under 505(b)(2), which can rely in part on data from existing reference drugs, can be developed and achieve FDA approval in as little as 30 months with fewer required clinical trials and at a much lower cost.

“Since the 505(b)(2) pathway became viable, it has rendered significant changes on the drug development landscape,” Stevens said. “Today, companies around the world are using 505(b)(2) to gain entry into the U.S. market, and a similar development pathway is being implemented in the E.U. and elsewhere. This is an important and increasingly complex area of drug development, and we’re here to help clients sort it out.”

Camargo is currently setting 505(b)(2) consultation appointments with Ken Phelps at DIA. To arrange an appointment, call 1.513.561.3329 or email rbell@camargopharma.com.

About Camargo Pharmaceutical Services

Camargo Pharmaceutical Services is your full-service drug development partner specializing in the 505(b)(2) process. We manage your plan throughout your development continuum, from feasibility assessments, formulation and testing, to conducting preclinical and clinical studies, to final submission. Connect with Camargo on LinkedIn, the President’s blog or visit www.camargopharma.com.



Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES