Regulatory - Pharmaceutical Executive


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

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.

Pharma Comes Under Fire for Jump in Rx Prices

December 9, 2009

Drug manufacturers came under fire at a hearing of the House Energy and Commerce?s health subcommittee for bumping drug prices 10 percent this year. Pharma claims rumors that it?s boosting costs in anticipation of healthcare reform are baseless, but the industry could be facing an uphill battle.

Congress Ups the Pharma Ante for Health Reform

November 24, 2009

House bill boosts rebates and opens the door to government price negotiations.

GAO Accuses FDA of Tardy Trial Data

October 28, 2009

The US oversight arm scripted a hefty report complaining that FDA is not moving fast enough when it comes to screening clinical trials data for drugs green lit through its expedited approval program.


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