Regulatory

Nov 01, 2010
Pharmaceutical Executive
By Pharmaceutical Executive Editors
A timeline of some of the landmark legislation, court decisions, and drug scandals that helped forge the FDA
Nov 01, 2010
Pharmaceutical Executive
By Pharmaceutical Executive Editors
Harvard professor Daniel Carpenter offers a piercing analysis of the FDA and sheds light on its biggest challenges
Aug 25, 2010
By Pharmaceutical Executive Editors
Results from a new study reveal that patients taking Takeda's diabetes treatment Actos have the same rate and kind of side effects as GSK's embattled Avandia. Is this a good sign?
Aug 04, 2010
By Pharmaceutical Executive Editors
In the wake of FDA's refusal to approve the lead drug in NicOx's pipeline, the French firm has decided to close its US headquarters.
Jul 14, 2010
By Pharmaceutical Executive Editors
Vivus's weight-loss drug Qnexa is heading into an FDA review with the backing of generally positive study data. Will FDA give the thumbs up? Depends on how severe it thinks the side effects are.
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.
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