Regulatory - Pharmaceutical Executive


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

Outrage Over Drug Prices

May 1, 2011

Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies

How US Health Reform Is Hitting Canada

April 1, 2011

Canada's Russell Williams, of Rx&D, talks about the impact of US health reform on his role as chief spokesman for the country's R&D industry

Challenges, Changes, Commitments

February 1, 2011

The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency

Politics & PDUFA

January 1, 2011

Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead

Is Euroland Following the US Disclosure Lead?

December 1, 2010

Cegedim survey documents whether European industry is ready for the challenge of new compliance and disclosure risks on promotional spend

New Ballgame in Washington

December 1, 2010

Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research

Science and Politics at the FDA

November 1, 2010

Harvard professor Daniel Carpenter offers a piercing analysis of the FDA and sheds light on its biggest challenges

How the FDA Grew

November 1, 2010

A timeline of some of the landmark legislation, court decisions, and drug scandals that helped forge the FDA

Actos Deemed as Safe as Avandia

August 25, 2010

Results from a new study reveal that patients taking Takeda's diabetes treatment Actos have the same rate and kind of side effects as GSK's embattled Avandia. Is this a good sign?


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