Regulatory - Pharmaceutical Executive

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

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.

Change Agent

January 6, 2010

FDA Commissioner Margaret Hamburg has a history of health advocacy and a clear mandate to transform the agency. But can she succeed where others have failed?

Sanofi Gets a Bad Batch of H1N1 Vaccines

December 16, 2009

Sanofi-Aventis is recalling hundreds of thousands of doses of the childrens' version of its H1N1 vaccine. Conspiracy theorists are going to have a field day.

Feds Team with Drugmakers to Curb Opioid Misuse

December 9, 2009

Painkiller abuse has become so prevalent that FDA is working with pharma to create a strategy for handling misuse of all drugs across the entire opioid category.

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