ABSTRACT

FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients, Part I, Hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Fifteenth Congress, First Session, March 21, 2017   [open pdf - 878KB]

This is the March 21, 2017 hearing titled "FDA [U.S Food and Drug Administration] User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients, Part I" before the Senate Committee on Health, Education, Labor, and Pensions. From the opening statement of Lamar Alexander: "The subject today is the Food and Drug Administration's Medical Device and Drug User Fees. It seems like a long time ago--but it really was not very long ago--that Congress passed the 21st Century Cures Act. Ninety-four Senators voted for it. President Obama and Vice President Biden were strongly in support of it, so was Speaker Ryan. Mitch McConnell called it the most important piece of legislation in the last Congress. [...] That bill was about moving medical products, drugs, and devices more rapidly in a safe way through the investment and the regulatory process, and into the hands of patients and doctors' offices. [...] We will hear from patients, device manufacturers, and brand and generic drug manufacturers in a second hearing, which is tentatively scheduled for April 4." Statements, letters, and materials submitted for the record include those of the following: Janet Woodcock, Peter Marks, and Jeffrey E. Shuren.

Report Number:
S. Hrg. 115-255; Senate Hearing 115-255
Publisher:
Date:
2018
Copyright:
Public Domain
Retrieved From:
Government Publishing Office: https://www.gpo.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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