Regulatory - Pharmaceutical Executive

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

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.

New Year, New Issues

January 1, 2012

Look for action in 2012 on drug access, shortages, innovation, and transparency.

Essential Questions for Essential Benefits

January 1, 2012

A key consideration under the Affordable Care Act is how states select plans for drug coverage.

The Payoff for Payers

December 1, 2011

Thorough risk assessment is essential before placing bets on good evidence that clears a path to approval.

Spotlight on OTCs

November 1, 2011

With OTCs challenging traditional approaches to quality, new opportunities are arising to support industry innovation and advance public health.

The Drug Shortages Struggle

November 1, 2011

Clamor for critical therapies prompts probes of prices, production practices.

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