Regulatory - Pharmaceutical Executive


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

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.

Patients Wade Into the Pricing Debate

September 1, 2012

Europe's fiscal crisis is becoming a new rallying cry for patient groups—but regional unity is still elusive.

The Endless Treadmill of End-of-Life Care

September 1, 2012

Bending the cost curve back to valuing the cycle of life.

Costs, Coverage, and Court Decisions

September 1, 2012

Its election season and drug pricing issues are once again front and center in the policy wars on managing the high cost of healthcare.

Compliance Kulture: The Facts Behind GSK's CIA

August 1, 2012

Big Pharma talks a lot about changing its business model to one that prioritizes quality and value over quantity and waste. While the healthcare "ecosystem" waits for pharma to grow into this model, government is delivering a comeuppance that actually puts it in the driver's seat and gaining the upper hand.

Who Will Pay for New Drugs?

July 1, 2012

Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies. Jill Wechsler reports.

Europe Responds to Medical Device 'Crisis'

June 1, 2012

A recent medical device controversy in France has pushed European health ministers to agree on a crisis management program for the troubled sector.


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