Regulatory

FDA officials willing to relocate to far-flung global cities should be congratulated for their herculean efforts to protect American patients. But funding cuts hamper the Agency's international presence.

Google "opioid abuse deterrence" and you'll find a lot of hits from lawyers and officials. What you won't find is a lot of expert thinking from FDA. That needs to change, says Peter J. Pitts of the Center for Medicine in the Public Health.

Cross-sector partnership seeks support for a pan-European system to keep fake drugs out, but obstacles are many.

Payers are seeking clear assessment of drug value to rationalize high drug prices. This issue has moved to center stage due to mounting concern over the high price for Gilead's Sovaldi, writes Jill Wechsler.

Despite provisions in the Affordable Care Act that require qualified health plans to cover 'basic' benefits, access to prescription drugs may be limited by high out-of-pocket costs and tight pharmacy management strategies.

Because of the tougher conditions they face and shifts in ownership and corporate strategy, EFPIA and EGA have started to work together much more closely.

Three strategic implications for pharma pricing strategies in India.

Accelerated testing and production create challenges in documenting product quality, writes Jill Wechsler.

Population health is the foundation for much of what is truly new in US health reform. Pharm Exec talks to Dr. David Nash, Dean of the Jefferson Medical University School of Population Health.

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

For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites.

Successful innovation now has to align with key metrics of value-can an old baseball metaphor help guide the way?

Pricing and personalized medicine are key themes shaping drug development and marketing

Let's Modernize Post-Approval Regulation of Prescription Drugs

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

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.

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

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

The US and EU move forward with measures to fortify the pharmaceutical supply chain, writes Patricia Van Arnum.

FDA wants pharma leaders to do more to ensure drug quality at home and abroad. Our Washington correspondent Jill Wechsler reports.

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

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

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

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

Value-based pricing in the United Kingdom is getting closer, but it remains out of focus.