From moving trucks to hitting “send”, biopharmaceutical companies need a stable and reliable system to submit New Drug Applications

11.01.13 | By

Less than 15 years ago, submitting an application to the Food and Drug Administration (FDA) for the approval of a new medicine generally involved loading docks, moving trucks, and enough paper to obliterate a small tree farm.  Today, those data once supplied on hundreds of thousands of paper pages are now a structured collection of electronic files submitted to the FDA through a secure portal. 

Fostering Opportunities in the Transatlantic Trade and Investment Partnership

10.31.13 | By

Yesterday, the Senate Finance Committee held its first hearing on the Transatlantic Trade and Investment Partnership (TTIP), a comprehensive free trade agreement that the U.S. and European Union have begun negotiating. America’s research-based biopharmaceutical companies believe that the TTIP negotiations provide an important opportunity to spur a new era of biomedical innovation in countries that are already global leaders on this front.

Regulations Governing Communication with Healthcare Providers Have Not Kept Pace with Advances in Technology

10.29.13 | By

Yesterday, I had the opportunity to speak at a conference of regulatory and compliance professionals – those who are dedicated to ensuring that regulation works.

Ensuring the security of our Nation's pharmaceutical supply chain

10.29.13 | By

Millions of prescriptions are filled every year in the United States and the patients who depend on these medications must have confidence in their safety and authenticity. From manufacturing to delivery, the pharmaceutical industry complies with regulations set by the U.S.

Developing Cures for Cancer

10.29.13 | By

A survey commissioned earlier this year by PhRMA shows 86 percent of Americans believe developing cures for more forms of cancer should be one of the top national health priorities.

Omaha -- Home of Steak, Warren Buffett And Cutting-Edge Biopharmaceutical Research

10.28.13 | By

Until this morning, on the rare occasions when I thought of Omaha, Nebraska, I would conjure up images of Warren Buffett, thick juicy steaks, a clean quiet Midwestern city and friendly, laid-back folks, not necessarily in that order.

I learned today that I was not inaccurate, all of the above is true,  but my picture was far from complete.

Research Supported by Biopharmaceutical Companies Boosts Economy, Benefits Local Patients

    

Alzheimer’s Association and the Alzheimer’s Drug Discovery Foundation

10.25.13 | By

Alzheimer’s has proven to be a stubborn, puzzling and perhaps even symbolic disease. In recent years, it has emerged as one of our greatest tests of biopharmaceutical science because of the disease’s vast and growing impact on the health of our aging population and the viability of our health care system.

Maximizing Prescription Quality Through ePrescribing

10.24.13 | By

Today, PhRMA will be hosting a stakeholder action group meeting with the National Council for Prescription Drug Programs (NCPDP) called “Maximizing Prescription Quality Through ePrescribing.” NCPDP is a non-for-profit, American National Standards Institute (ANSI) certified standards development organization.

Advancing Cancer Research

10.24.13 | By

How can we continue to advance cancer research and improve patient outcomes in an era of cost containment?  The issue was recently highlighted in a New York Magazine article that only provided part of the story on cancer progress and cost containment.  Last week I had the opportunity to tackle this question as part of a roundtable that convened leaders from across the cancer community.

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