Regulatory - Pharmaceutical Executive


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

Battles over Biosimilars

July 1, 2011

Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game

Optimizing your Value with Payers

June 1, 2011

Successful negotiations require a willingness to take risks and an ability to adapt

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


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