Regulatory - Pharmaceutical Executive

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

Not Much Ado About the ACA

October 1, 2013

With key provisions of the Affordable Care Act set to launch this month, industry veteran Mason Tenaglia says the impact all depends on what you sell and where you sit.

Divining the Future of Devices

October 1, 2013

European efforts to crack down on safety and pricing issues in the marketing of medical devices may portend long-term problems for Big Pharma.

Making Sense of the Sunshine Act

September 1, 2013

The Sunshine Act's Open Payments spending disclosure program is now live. The government's lead compliance officer explains how it will work.

Pharma Bids for European Funding in New Research Program

August 1, 2013

The ?70 billion budget is still subject to final agreement on the European Union's overall spending plans for 2014-2020.

Breaching the Great Wall

August 1, 2013

With a revision of China's basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation.

Pharmacy Compounding: What's Ahead for Manufacturers

June 1, 2013

Compounders are under increased scrutiny following last year's spinal meningitis outbreak.

Unlocking the Key to Public Funding in Brazil

June 1, 2013

What is really driving decision making by the new Brazilian HTA agency? A look at appraisals issued in the first year.

Manufacturers Under Pressure to Manage Painkillers

May 6, 2013

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

European Biotech Struggles to Thrive

May 6, 2013

While not as bleak as believed, the outlook of European biotech sector is struggling compared with its US counterpart.

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