Regulatory

Dec 09, 2009
By Pharmaceutical Executive Editors
Painkiller abuse has become so prevalent that FDA is working with pharma to create a strategy for handling misuse of all drugs across the entire opioid category.
Nov 24, 2009
House bill boosts rebates and opens the door to government price negotiations.
Oct 28, 2009
Pharmaceutical Executive
By Pharmaceutical Executive Editors
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.
Jul 22, 2009
Pharmaceutical Executive
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.
Jul 08, 2009
Pharmaceutical Executive
By Pharmaceutical Executive Editors
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.
Jul 01, 2009
By Pharmaceutical Executive Editors
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.
Jun 17, 2009
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Feds claim results of study comparing car crash deaths and children on ADHD drugs were not paramount to pulling kids off of ADHD treatments.
Jun 11, 2009
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.
Jun 03, 2009
Pharmaceutical Executive
By Pharmaceutical Executive Editors
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
Pharmaceutical Executive
By Pharmaceutical Executive Editors
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."
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