X

Stay Connected

Sign Up for Updates

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

FDA needs best and brightest to advance a new era of medicine with America’s biopharmaceutical companies

By Richard Moscicki, M.D.  |    October 16, 2018
The U.S Food and Drug Administration (FDA) plays a critical role in protecting and promoting the health of all Americans. Every day, the FDA does important work to ensure the safety, efficacy and...   Read More

Bringing innovation to clinical trial design

By Richard Moscicki, M.D.  |    April 23, 2018
Clinical trials are critical to the discovery and development of innovative medicines that enable patients to live longer, healthier lives. As the biopharmaceutical industry works to identify,...   Read More

ICYMI: Why 2017 medicine approvals matter

By Andrew Powaleny  |    January 12, 2018
This week, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its 2017 New Drug Therapy Approvals report. Last year marked an extraordinary...   Read More

The next five years of PDUFA VI: Driving the availability of innovative treatments for patients

By Bill Chin, M.D.  |    October 2, 2017
Yesterday, October 1, marked the first day of implementation for PDUFA VI, the next iteration of the Prescription Drug User Fee Act (PDUFA) and one of the best tools that the U.S. Food and Drug...   Read More

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

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

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

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

What you need to know about PDUFA VI

By Andrew Powaleny  |    July 27, 2016
The U.S. Food and Drug Administration (FDA) recently released its performance goals letter for the sixth installment of the Prescription Drug User Fee Act (PDUFA). The letter comes after months of...   Read More

Search the Catalyst

View Posts by Topic

see all

Subscribe to Email Updates