Regulatory - Pharmaceutical Executive


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

Obamacare Will Boost Private Managed Care

May 1, 2013

Public access expansion under the ACA isn't really a "government takeover."

Is That VBP on the Horizon, or a Mirage?

May 1, 2013

Value-based pricing in the United Kingdom is getting closer, but it remains out of focus.

Is National Drug Pricing Freedom in Europe Nearing its Expiry Date?

April 1, 2013

The European Union's attempt to update its transparency rules sparks new debate.

Who's Really in Charge of European Drug Registration?

March 1, 2013

European Commision blocks the authorization of a life-saving liver drug outside of France.

Another Round of FDA Legislation?

March 1, 2013

Pressure for action on key enforcement and regulatory issues may prompt congressional action this year.

Turkey: A Promise Restored?

February 1, 2013

After a decade of strife, the dialogue between industry and government appears to have entered a positive new phase. Julian Upton reports.

Compliance in the C-Suite

January 1, 2013

Compliance officers have risen into management's highest ranks, by choice in some organizations, and by government decree in others. Either way, their importance as a strategic partner can hardly be understated.

The Puzzle Master: EMA's Guido Rasi

December 1, 2012

Europe's chief regulator charts a strategy from many moving parts. Dr Guido Rasi talks to Pharm Exec's William Looney.

Germany's Price Reform Revolution

December 1, 2012

At two years and counting, what's the secret of success in negotiating pricing under the new AMNOG legislation?


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