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Setting the record straight on accelerated approval

By Andrew Powaleny  |    May 22, 2023
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...   Read More

FDA should remain the authority on the safety and effectiveness of medicines

By Jim Stansel  |    April 12, 2023
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...   Read More

What you should know about real-world evidence and drug development

By Sarah K. Martin  |    December 19, 2022
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...   Read More

Three things to know about the accelerated approval pathway

By Lucy Vereshchagina  |    December 12, 2022
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...   Read More

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

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

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