Regulatory - Pharmaceutical Executive


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

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.

Comparative Effectiveness Research: Challenges for Pharma

May 9, 2012

Switching Rx drugs to OTC and adding comparative data could broaden access to treatment, writes Jill Wechsler.

Government: Big Pharma's Best Friend in Emerging Markets?

May 1, 2012

To gain market access in emerging markets, pharma companies face pressure to offer a convincing Corporate Value Proposition to governments.

Providing Access Now

April 1, 2012

While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help.

How Can We Fix the FDA?

March 1, 2012

How can we better balance addressing medical needs with ensuring that new drugs are safe and effective? Ron Cohen reports.

When Talk is Not So Cheap

March 1, 2012

FDA and industry are pushing user fees, while they struggle with curbs on communications.


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