Regulatory - Pharmaceutical Executive


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

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.

Discussions About Drug User-Fees

April 14, 2010

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.

Controlled-Release OxyContin Approved as Rx ODs Spike

April 7, 2010

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.

FDA Gives Red Light to Ranbaxy for Generic Flomax

March 3, 2010

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.


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