Regulatory - Pharmaceutical Executive


New developments and strategies for success in dealing with FDA, OIG, SEC, EMEA, and more.

Science and Politics at the FDA

November 1, 2010

Harvard professor Daniel Carpenter offers a piercing analysis of the FDA and sheds light on its biggest challenges

How the FDA Grew

November 1, 2010

A timeline of some of the landmark legislation, court decisions, and drug scandals that helped forge the FDA

Actos Deemed as Safe as Avandia

August 25, 2010

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?

NicOx Shutters HQ After Approval Fail

August 4, 2010

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.

FDA to Weigh In on Obesity Drug

July 14, 2010

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.

Berwick Appointed Head of CMS

July 8, 2010

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.

Road Map for REMS

July 1, 2010

FDA's risk-reduction requirements could be the bridge to a bright new future for the pharma industry.

FDA Prepares to Walk the Opiate REMS Line

June 30, 2010

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.

Sunshine Laws Stump Compliance Departments

April 28, 2010

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.


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