New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.
October 28, 2009
By:George Koroneos, Online Content & News Editor
The US oversight arm scripted a hefty report complaining that FDA is not moving fast enough when it comes to screening clinical trials data for drugs green lit through its expedited approval program.
 |
July 22, 2009
By:Jill Wechsler
Collins seeks to parlay genomic discoveries into new biomedical therapies. Comparative effectiveness research, he says, should identify subpopulation responses to treatment and support personalized medicine.
|
July 8, 2009
By:George Koroneos, Online Content & News Editor
Pain medications containing propoxyphene could lead to overdose and death, according to new labeling mandated by FDA. However, public requests to take these drugs (including Darvon and Darvocet) off the market have been denied.
|
July 1, 2009
Patents are an important tool for protecting innovative products, uses or processes intended for commercialization. A granted patent provides a limited monopoly, normally for up to 20 years from the filing date of a patent application, giving a patent owner the right to prevent other parties from making, stocking, selling, using or importing the patented invention without the patent owner's permission. A theoretical ideal for an innovator would be to obtain a patent in all countries of the world. However, patents must be sought and enforced in each territory where protection is desired because a global patent does not (yet) exist. For cost reasons, a decision is usually made as to where to file and process patent applications.
|
June 11, 2009
By:George Koroneos, Online Content & News Editor
The Word Health Organization just bumped the H1N1 influenza to pandemic alert phase 6 (the highest alert level), making it the first worldwide pandemic in 41 years.
|
June 3, 2009
By:George Koroneos, Online Content & News Editor
The feds green lit a task force charged with easing the flow of communication between FDA, pharma companies, and the general public. While the team is being billed as a task force for transparency, it?s still unclear what is being revealed.
|
May 27, 2009
By:George Koroneos, Online Content & News Editor
You know those loud soundtracks and distracting visuals during the safety information in your TV ads? Critics have been complaining about them, and new draft guidance from FDA is calling them a "no-no."
|
April 8, 2009
By:George Koroneos, Online Content & News Editor
FDA is cracking down on content in search engine advertisements. The argument is that there is a serious deficiency of risk information in the tiny link ads that appear on search ads. With pharma already wary of marketing online, will FDA’s tactic hurt future Web campaigns?
|
| 
PharmExec Blog
Follow Us
RSS
Bookstore
What's the best managed pharma? Professor Bill Trombetta of Saint Joseph's University attempts to answer the question in Pharm Exec's Industry Audit.
The most respected annual ranking of top 50 pharmaceutical companies by prescription drug sales... Who's in, who's back, and who's out?
Super Reps book trilogy by Dr. Lou Sawaya MD, MBA
Don't miss this Podcast series commemorating the 20th anniversary of HBA's Woman of the Year Award with interviews spanning two decades of change makers.
Conducting clinical trials in emerging regions can give you the edge. Five Quintiles experts share their insights into navigating the global regulatory landscape.