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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.

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

PhRMA & BIO release joint principles on communications with health care professionals and payers

By Jeff Francer  |    July 27, 2016
This blog post is authored by Jeffrey Francer (PhRMA) and Deborah Shelton (BIO). We are in an era of data-driven medicine. Patients, caregivers, health care professionals and insurers want more...   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

Advancing the science of hope

By Andrew Powaleny  |    June 13, 2016
Developing new medicines is a challenging undertaking, and the science is only getting harder. As our understanding of science grows, so does the complexity of developing new medicines,...   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

The Science of Hope: Understanding biomarkers

By Andrew Powaleny  |    May 18, 2016
In the age of personalized medicine, biomarkers (short for “biological markers”) are emerging as important tools in drug development. A biomarker is a measure or physical sign that can be used to...   Read More

Fact Check Friday: Biopharmaceutical company communications with payers

By Andrew Powaleny  |    April 29, 2016
Today, we’re examining how and what biopharmaceutical companies communicate with payers about a medicine prior to its approval by the U.S. Food and Drug Administration (FDA). MYTH:...   Read More

FDA issues draft biosimilars labeling guidance

By Andrew Powaleny  |    April 12, 2016
Labeling is an important aspect of the U.S. Food and Drug Administration (FDA) prescription drug approval process. FDA-approved prescription drug labeling is the most authoritative mechanism for...   Read More

Phased-in approach offers best hope for FDA’s proposed quality metrics program

By Camille Jackson  |    April 7, 2016
In July 2015, the U.S. Food and Drug Administration (FDA) issued draft guidance for industry requiring manufacturers to provide certain manufacturing data on an annual basis. The FDA’s Center for...   Read More

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