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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.
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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).
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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...
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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).
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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...
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The FDA Office of Minority Health and Health Equity: Working to advance health equity through diversity in research
By Guest Contributor | May 12, 2021
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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2020 FDA approvals show innovation despite COVID-19 pandemic challenges
By Andrew Powaleny | January 26, 2021
A new report from the U.S. Food and Drug Administration (FDA) notes that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year. These figures are in addition to...
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Nearly 400 cell and gene therapies in development to target a broad range of diseases
By Andrew Powaleny | March 10, 2020
In 2017, the U.S. approved its first cell and gene therapy, making the idea of altering a gene to cure or treat a disease a reality. As the increasing pace of R&D propels cell and gene therapy...
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ICYMI: 2019 brings innovative medicines to patients
By Andrew Powaleny | January 17, 2020
New reports from the U.S. Food and Drug Administration (FDA) show a total of 55 novel new medicines were approved in 2019. Among these, 48 were approved by the Center for Drug Evaluation and...
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PhRMA comments to Congress on Cures 2.0 call to action
By Anne McDonald Pritchett, PhD | December 18, 2019
As new therapies continue to revolutionize the treatment of many diseases, it is positive news that policymakers in Washington are discussing ways to ensure patient access to new treatments and...
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