Regulatory

Feb 10, 2010
By Pharmaceutical Executive Editors
The popular antidepressant is associated with up to 91 percent increase in risk of death in patients undergoing tamoxifen treatment for breast cancer.
Feb 10, 2010
Added funds for FDA to come from new user fees, largely for food and tobacco regulation.
Jan 13, 2010
By Pharmaceutical Executive Editors
The push for government transparency continues with Phase I of FDA's plan to expose the inner workings of that secretive cabal known as the Food and Drug Association. First up, fancy new FAQs.
Jan 13, 2010
By Pharmaceutical Executive Editors
At time when people can't even get a 3 percent cost-of-living increase, how can pharma justify price hikes pushing 500 percent (in some categories). A new study by the government's General Accountability Office examines why drug products took a massive price leap in recent years.
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.
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