Regulatory - Pharmaceutical Executive


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

Growing Pains: The European Medicines Agency at 20

February 3, 2014

Reflector looks at the growing pains of the European Medicine Agency (EMA) as it faces the key policy challenges of 2014.

Let's Modernize Post-Approval Regulation of Prescription Drugs

November 27, 2013

Let's Modernize Post-Approval Regulation of Prescription Drugs

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.


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