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We are creating a place where we can share ideas, provide the perspective of America's biopharmaceutical companies and, most importantly, listen to you.

Why reauthorization of PDUFA matters

By Andrew Powaleny  |    July 13, 2017
Last night, the Prescription Drug User Fee Act (PDUFA), was reauthorized by the House of Representatives. PDUFA provides the U.S. Food and Drug Administration (FDA) with necessary resources to...   Read More

A critical opportunity to prevent prescription drug abuse

By Anne McDonald Pritchett, PhD  |    June 2, 2017
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently cited addressing the opioid crisis as his highest priority. As someone who has spent the bulk of my career focused on...   Read More

Guest Post: The importance of a modern FDA in drug discovery

By Guest Contributor  |    March 22, 2017
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest...   Read More

Building on the promise of personalized medicine

By Andrew Powaleny  |    November 16, 2016
PhRMA’s member companies are on the leading edge of personalized medicine development– an area that is transforming health care, improving patient outcomes and creating health system efficiencies....   Read More

What are REMS? These extra steps are helping protect patient health

By Bill Chin, M.D.  |    October 6, 2016
As a physician and chief medical officer at PhRMA, I know how important it is to ensure that patients have access to safe, innovative medicines to help them live longer, healthier lives. But...   Read More

Harnessing the power of real-world evidence to benefit patients through PDUFA VI

By Andrew Powaleny  |    September 6, 2016
America’s biopharmaceutical researchers are in a golden era of medical research, discovery and development for patients. Rapid advances in technology and science have enhanced our ability to use...   Read More

How modernizing FDA regulations can benefit patients, providers and payers

By Andrew Powaleny  |    September 1, 2016
Yesterday, the U.S. Food and Drug Administration (FDA) announced a two-day hearing slated for November 9 and 10, seeking public input as the agency works to review and potentially revise its...   Read More

Improving FDA’s combination product review process could increase epinephrine auto-injector competition

By Stephen J. Ubl  |    August 30, 2016
Combination products that consist of a medicine and delivery device are important treatment options for patients and have the potential to improve public health. Innovator companies invest in...   Read More

Looking ahead to PDUFA VI

By Sascha Haverfield  |    August 11, 2016
Next Monday, PhRMA and BIO will participate alongside patient advocates and key stakeholders in the U.S. Food and Drug Administration’s (FDA) public meeting on the reauthorization of the ...   Read More

Guest Post: New bioethical Points to Consider on truthful and non-misleading product communication

By Guest Contributor  |    August 4, 2016
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest...   Read More

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