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PDUFA and BsUFA reauthorizations are wins for patients

By Stephen J. Ubl  |    October 5, 2022
America relies on the U.S. Food & Drug Administration (FDA) to keep pace with the scientific advancements happening every day in labs across the country. That’s why the recently enacted Prescription...   Read More

Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines

By Andrew Powaleny  |    September 12, 2022
As we’ve discussed on this blog before, timely reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) is critical to sustaining the U.S. Food and Drug...   Read More

Word of the Month: Biomarkers and surrogate endpoints

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

ICYMI: New resource catalogs biopharmaceutical industry lessons learned from COVID-19

By Gabby Migliara  |    April 28, 2022
Since the start of the pandemic, America’s biopharmaceutical companies have worked around the clock to research, develop and manufacture treatments and vaccines to fight COVID-19. We’ve made...   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

World AIDS Day: Remembering those we’ve lost and exploring the continued fight against HIV/AIDS

By Andrew Powaleny  |    December 1, 2021
Today, as we mark World AIDS Day and commemorate those who lost their lives to AIDS-related illnesses, we want to recognize the impressive advancements in HIV/AIDS scientific research and drug...   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

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