Ensuring timely reauthorization of PDUFA and BsUFA

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

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...
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The importance of timely PDUFA and BsUFA reauthorization

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

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

Last week, the U.S. Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III.
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Meeting Tomorrow: Looking ahead to PDUFA VII

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).
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The impact of monoclonal antibodies and COVID-19 recovery

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...
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PDUFA VII is critical for future biopharmaceutical innovation and for patients

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).
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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...
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The FDA Office of Minority Health and Health Equity: Working to advance health equity through diversity in research

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...
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