Setting the record straight on accelerated approval

As we’ve discussed on this blog before, the U.S. Food and Drug Administration’s (FDA) accelerated approval program has served as a critical lifeline for patients with serious and life-threatening...
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FDA should remain the authority on the safety and effectiveness of medicines

Recent district court rulings set an alarming precedent that calls into question the authority of the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of new...
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What you should know about real-world evidence and drug development

Recently, industry leaders, regulators, academics, data partners, and patient advocates gathered in Washington, D.C., to discuss using real-world data and real-world evidence for regulatory...
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Three things to know about the accelerated approval pathway

If you or a loved one were to receive a diagnosis of a serious or life-threatening disease, you would likely want access to a U.S. Food and Drug Administration (FDA) approved safe and effective...
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PDUFA and BsUFA reauthorizations are wins for patients

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...
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Word of the Month: Biomarkers and surrogate endpoints

What is a biomarker?
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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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