Regulatory

Jul 08, 2010
By Pharmaceutical Executive Editors
With a long, hard fight looming, President Obama decided to go around Congress to install Don Berwick, founder of the Institute for Healthcare Improvement, as the top administrator of the Centers for Medicaid and Medicare Services.
Jul 01, 2010
Pharmaceutical Executive
By Pharmaceutical Executive Editors
FDA's risk-reduction requirements could be the bridge to a bright new future for the pharma industry.
Jun 30, 2010
By Pharmaceutical Executive Editors
FDA's meeting on the adoption of REMS for certain prescription opioids doesn't begin until July 22, but the agency's proposal released Tuesday portends a meeting fraught with conflict over the balance between curbing abuse and protecting patient access.
Apr 28, 2010
By Pharmaceutical Executive Editors
A new Cegedim Dendrite study shows just how ill-equipped pharmaceutical companies are to deal with spending disclosure legislation, and how many are turning to third parties to do the job.
Apr 14, 2010
By Pharmaceutical Executive Editors
The Prescription Drug User Fee Act will expire in 2012 and FDA is working hard to renegotiate the act before that end date. The contenders: in one corner, the pharma industry; in the other, the general public and consumers - and just about everyone has an opinion about what needs to be changed.
Apr 07, 2010
By Pharmaceutical Executive Editors
FDA approves a new formulation of Purdue Pharma's notoriously addictive opioid. This version is supposed to make it harder for the drug to be repurposed for nefarious consumption.
Mar 03, 2010
By Pharmaceutical Executive Editors
The Indian generic firm Ranbaxy was dealt another blow this week as its version of the enlarged prostate drug Flomax was denied approval in the US just as it was about to go to market.
Mar 01, 2010
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Obligations to fund and support costly studies can extend beyond the period of market exclusivity, giving generics competitors an advantage.
Feb 24, 2010
By Pharmaceutical Executive Editors
GSK is coming under serious fire again from the FDA and Senate, who say the company resorted to scientific flimflammery to keep researchers quiet about Avandia's safety risks.
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.
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