Regulatory - Pharmaceutical Executive


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

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?

OTC Crunch Time in California

November 1, 2012

Over-the-counter products face a new wave of regulation.

Budgets, Biosimilars, and Bad Ads

November 1, 2012

While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives, writes Jill Wechsler.

Richard Bergström — Europe's Medicine Man

October 1, 2012

The new head of EFPIA faces a Promethean challenge: selling the merits of costly science and innovation in an era of bristling competition, fiscal crisis, and declining demographics.


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