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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.

Biomarkers and surrogate endpoints are critical tools for drug development

By Matthew Norawong  |    July 11, 2022
We are committed to engaging a wide range of audiences and having a dialogue on opportunities to create a better health care system. We believe health literacy can not only help patients make...   Read More

Ensuring timely reauthorization of PDUFA and BsUFA

By Matthew Norawong  |    May 11, 2022
Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the...   Read More

The accelerated approval pathway: Helping patients with serious or life-threatening diseases

By Andrew Powaleny  |    March 17, 2022
Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing...   Read More

The importance of timely PDUFA and BsUFA reauthorization

By Lucy Vereshchagina  |    February 3, 2022
Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and...   Read More

ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients

By Richard Moscicki, M.D.  |    January 26, 2022
The U.S. Food and Drug Administration (FDA) approved a total of 60 new drugs in 2021. A new report from the FDA catalogs 50 new approvals by the Center for Drug Evaluation and Research (CDER)....   Read More

Biosimilar User Fee Act (III) Performance Goals Letter will help increase options for patients and promote competition

By Richard Moscicki, M.D.  |    September 28, 2021
Last week, the U.S. Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III.   Read More

Meeting Tomorrow: Looking ahead to PDUFA VII

By Andrew Powaleny  |    September 27, 2021
Tomorrow, PhRMA will participate at the U.S. Food and Drug Administration’s (FDA) public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA VII).   Read More

The impact of monoclonal antibodies and COVID-19 recovery

By Andrew Powaleny  |    September 2, 2021
As the United States and world continue to fight the COVID-19 pandemic, America’s biopharmaceutical research companies continue to do our part in fighting this deadly virus. Decades of scientific...   Read More

PDUFA VII is critical for future biopharmaceutical innovation and for patients

By Richard Moscicki, M.D.  |    August 23, 2021
Today, the U.S. Food and Drug Administration (FDA or Agency) released its performance goals letter for the seventh installment of the Prescription Drug User Fee Act (PDUFA).   Read More

How strengthening the biosimilar marketplace benefits patients

By Andrew Powaleny  |    May 18, 2021
Biologics are medicines that are made from living organisms through highly complex manufacturing processes and include a wide variety of medicines such as therapeutic proteins, monoclonal antibodies...   Read More

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