Expanding Knowledge to Enhance Patient Wellness

11.02.13 | By

The old adage that 'you learn something new every day' doesn’t apply to the biopharmaceutical industry; for those researching and developing new medicine, it would be more accurate to say you learn something new every few minutes. Our member companies continue to push the limits of research, and that process keeps our work consistently exciting.
 

Use of SI Units in Regulatory Submission

Washington, D.C. (October 31, 2013) — Pharmaceutical Research and Manufacturers of America (PhRMA) Vice President of Scientific and Regulatory Affairs Sascha Haverfield, PhD, issued the following statement on the recent announcement by the Food and Drug Administration (FDA) regarding the use of Systeme International (SI) units in regulatory submissions:

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.

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