Regulatory - Pharmaceutical Executive



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.

FDA Unveils Guidance for Biosimilar Development

February 10, 2012

After months of anticipation, FDA finally issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

As the Compliance Net Tightens...

February 1, 2012

Time to stop and think about CMS's 'Proposed Rule' on transparency and what it means for the life sciences business model.

Costs and Benefits of Health Reform

February 1, 2012

Will expanded markets and ACOs offset higher rebates, added fees, and closer scrutiny of marketing and prices?

FDA Social Media Guidelines: Irresponsible?

February 1, 2012

After two years of waiting, FDA issued the first in a series of planned guidelines on social media at the end of last year. We look at some of the experts' reactions.


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