Regulatory

Jan 06, 2010
Pharmaceutical Executive
FDA Commissioner Margaret Hamburg has a history of health advocacy and a clear mandate to transform the agency. But can she succeed where others have failed?
Dec 16, 2009
Sanofi-Aventis is recalling hundreds of thousands of doses of the childrens' version of its H1N1 vaccine. Conspiracy theorists are going to have a field day.
Dec 09, 2009
Drug manufacturers came under fire at a hearing of the House Energy and Commerce?s health subcommittee for bumping drug prices 10 percent this year. Pharma claims rumors that it?s boosting costs in anticipation of healthcare reform are baseless, but the industry could be facing an uphill battle.
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.
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