Regulatory - Pharmaceutical Executive

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

Proven Reliability in Temperature Controlled Shipping

February 8, 2010

American Airlines Cargo has implemented a high-visibility, multi-layered system for temperature-controlled shipping that has gained accreditation in 60 cities in 24 countries worldwide. American?s ExpediteTC solution delivers the kind of specialized air cargo expertise demanded by pharmaceutical customers and their freight forwarders.

Data Governance: Business Data You Can Believe In

February 1, 2010

Bad data ? and a lack of good data management practices ? can cost your business millions of dollars every year. You have to treat your data like every other valuable asset in your business: You must protect it, nurture it and ensure that, like any asset, it?s in the best condition possible.

Business Intelligence Case study: Abbott Laboratories

February 1, 2010

Abbott Laboratories tapped Kalido?s model-driven data warehousing infrastructure to revamp?and revive?an overworked BI system. Executives can view accurate, timely data in each of several different contexts?historical, current, or future. The new system also gives Abbott?s sales and marketing executives better insight into how efficiently the company is allocating its sales and marketing investments, particularly in emerging markets.

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.

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.

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.

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.

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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