Regulatory - Pharmaceutical Executive

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

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'...

The Supremes Shape Pharma

August 1, 2011

A number of important decisions from the Supreme Court will affect drug marketing, research, and regulation

Mind the Gap!

August 1, 2011

No one doubts the importance of health expenditures ? but then, euros, like dollars, don't grow on trees

Europe in HTA Gridlock

August 1, 2011

HTAs are gridlocked by diverse national requirements, a lack of alignment on processes, and even on the value of their outcomes.

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