Regulatory - Pharmaceutical Executive


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

The Supremes Shape Pharma

August 1, 2011

A number of important decisions from the Supreme Court will affect drug marketing, research, and regulation

Mind the Gap!

August 1, 2011

No one doubts the importance of health expenditures ? but then, euros, like dollars, don't grow on trees

Europe in HTA Gridlock

August 1, 2011

HTAs are gridlocked by diverse national requirements, a lack of alignment on processes, and even on the value of their outcomes.

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


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