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  1. Congressional Testimony

Testimony | In Person

Event Title
Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices
May 22, 2024

Testimony of
Patrizia Cavazzoni,, M.D.
Director - Center for Drug Evaluation and Research

Peter Marks, M.D., PhD.
Director - Center for Biologics Evaluation and Research (CBER)

Jeff Shuren, M.D., J.D.
Director - CDRH Offices: Office of the Center Director


Chair Guthrie, Ranking Member Eshoo, and members of the Subcommittee, thank you for the opportunity to testify before you to discuss the Food and Drug Administration’s (FDA or the Agency) efforts to promote innovation and protect the public health.

FDA helps ensure that Americans can have confidence in the medical products they are using. The Agency is charged with overseeing and helping to advance innovations upon which patients, healthcare providers, and the U.S. healthcare system depend.

Staying ahead of the rapid advancements made across regulated industries is a fundamental but challenging aspect of FDA’s work. Biomedical discovery, science, computing, and engineering take decades to mature as part of the development of safe and effective products. FDA is most effective when we balance innovation and our obligation to ensure that therapies are safe and effective. User fees are an integral part of these efforts and support our mission of protecting and promoting the public health, with the ultimate goal of getting treatments to the patients who need them. User fees have supported programs to strengthen input from patients and enhance product safety, resulted in reduced time to regulatory actions, supported innovative pilot programs to identify regulatory efficiencies, and allowed the Agency to recruit and retain top talent and expertise. The user fee programs helped us navigate the COVID-19 pandemic and through the latest reauthorization, will allow us to continue to support the modernization of clinical trials, leverage regulatory flexibilities to address rare diseases, and ensure medical devices are designed with adequate cybersecurity measures in place. Timely and continued reauthorization of these programs is imperative and sets up the Agency to successfully continue its important work in the face of public health emergencies, natural disasters, and times of rapid innovation. 

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