Regulatory - Pharmaceutical Executive


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

Educating Physicians

June 1, 2011

FDA's opiod REMS implies there is still value in industry-sponsored CME

How to Be More Truthful

June 1, 2011

Suggestions for testing new ways of addressing difficult issues of risk

Federal Appeals Court Lifts Ban on Funding for Embryonic Stem Cell Research

May 5, 2011

A federal appeals court has lifted a ban on federal funding for embryonic stem cell research.

The Elusive Single-Point-of-Entry

May 1, 2011

Considering Big Pharma's trade objectives, the success of regional regulatory harmonization is not insignificant

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


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