Regulatory - Pharmaceutical Executive

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

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.

Managing REMS for the Long Term

March 1, 2010

Obligations to fund and support costly studies can extend beyond the period of market exclusivity, giving generics competitors an advantage.

Avandia 2: Ethical Boogaloo?

February 24, 2010

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.

Study Links Paxil to Breast Cancer Patient Deaths

February 10, 2010

The popular antidepressant is associated with up to 91 percent increase in risk of death in patients undergoing tamoxifen treatment for breast cancer.

No Real New Money for Drug Regulation

February 10, 2010

Added funds for FDA to come from new user fees, largely for food and tobacco regulation.

GAO Seeks Price Spike Explanation

January 13, 2010

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.

FDA Basics Brings the Agency Out of the Closet

January 13, 2010

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.

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