Regulatory - Pharmaceutical Executive

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

Transparency Troubles for Pharma

November 1, 2013

High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise.

Supply Chain: Scanning the Future

November 1, 2013

The US and Europe are moving toward the enactment of new legislation that will change the way pharma products are handled and shipped throughout the supply chain.

Big Pharma's Newest Cost Center

October 31, 2013

As the burden of promotional disclosure expands beyond US shores, understanding the rules and then controlling the cost of compliance is a strategic necessity.

Brand-Generic Wars Heat Up

October 1, 2013

Tension mounts over biosimilars, co-pay coupons, trade, and testing.

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.

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