Regulatory

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.

Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.

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.

Transparency initiatives are multiplying, affecting research, marketing and compliance.

How will the biopharmaceutical industry contemplate product innovation in the changing landscape of US healthcare?

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.

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

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

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

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

Rising costs will mean a drop in anticipated NDAs next year, reflecting an ever-longer and more costly drug-development process that is squeezing pharma investment in R&D.

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.

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

Rate cuts and fraud concerns create problems for Part D plans and Part B providers.

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.