Regulatory - Pharmaceutical Executive

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

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.

Janet Woodcock: At the Helm of Industry

October 1, 2011

Janet Woodcock, MD, Director, FDA Center for Drug Evaluation and Research

Sir Michael Rawlins: Regulation and Reputation

October 1, 2011

Sir Michael Rawlins, Chairman of the UK National Institute for Health and Clinical Excellence

Rebates and Reform

September 1, 2011

User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.

Congressional Investigations: What Every Exec Should Know

August 1, 2011

When faced with legislative scrutiny, be prepared, be truthful, and don't be afraid to say 'I don't know'...

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