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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.

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

Video: How can biomarkers and surrogate endpoints enhance R&D of medicines?

By Andrew Powaleny  |    July 14, 2016
In the age of personalized medicine, biomarkers are emerging as important tools in drug development. A biomarker is a measure or physical sign that can be used to determine how the body is...   Read More

Why incorporating patients’ perspectives matters

By Andrew Powaleny  |    June 10, 2016
America’s biopharmaceutical research companies have long been dedicated to researching and developing new medicines that enable patients to live longer, healthier lives. Patients’ voices are...   Read More

PDUFA 101

By Andrew Powaleny  |    September 3, 2015
With Prescription Drug User Fee Act (PDUFA) VI FDA-Industry negotiations about to commence, we’re taking a look at what PDUFA is, how it works, and explaining why it has been a tremendous success...   Read More

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