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We are creating a place where we can share ideas, provide the perspective of America's biopharmaceutical companies and, most importantly, listen to you.

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

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).   Read More

3 things that support robust biopharmaceutical research and development

By Richard Moscicki, M.D.  |    June 29, 2021
Rapid advances in scientific discovery have ushered in a new era of medicine, transforming our ability to treat, and in some cases cure, many of the most challenging diseases, including cancer,...   Read More

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...   Read More

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...   Read More

Clinical Trials Awareness Week: Celebrating innovation in clinical research

By Richard Moscicki, M.D.  |    May 15, 2019
This week is Clinical Trials Awareness Week — an annual event to recognize the important role clinical trials play in helping develop safe and effective medicines.   Read More

Rare Disease Day: Unmet medical need inspires biopharmaceutical innovation

By Richard Moscicki, M.D.  |    February 28, 2019
Today is Rare Disease Day, an annual reminder of the incredible community of patients living with a rare disease. In the U.S., rare diseases are classified as conditions that affect fewer than...   Read More

Putting 2018 medicine approvals in context

By Andrew Powaleny  |    January 23, 2019
Last year, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved a record number of novel new medicines with 59 new molecular entities (NMEs). While...   Read More

FDA needs best and brightest to advance a new era of medicine with America’s biopharmaceutical companies

By Richard Moscicki, M.D.  |    October 16, 2018
The U.S Food and Drug Administration (FDA) plays a critical role in protecting and promoting the health of all Americans. Every day, the FDA does important work to ensure the safety, efficacy and...   Read More

Bringing innovation to clinical trial design

By Richard Moscicki, M.D.  |    April 23, 2018
Clinical trials are critical to the discovery and development of innovative medicines that enable patients to live longer, healthier lives. As the biopharmaceutical industry works to identify,...   Read More

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