GDUFA/BsUFA User Fees | Association for Accessible Medicines
AAM All Access Podcast - AAM CEO Dan Leonard convenes industry and policy experts to explore why the Inflation Reduction Act (f/k/a Build Back Better) reduces generic and biosimilar competition.



Please see below for shareable resources, press releases and other content relating to this issue. You can also use the search bar in the header of our website to search for specific keywords across all content on the site.

PDFJan 26, 2022Ericka Nguyen
GDUFA Reauthorization: A Primer
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PDFJan 26, 2022Ericka Nguyen
BsUFA Reauthorization: A Primer
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PDFOct 29, 2021Erica Klinger
Generic Drug User Fee Amendments (GDUFA III)
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PDFSep 21, 2021Erica Klinger
The Biosimilar User Fee Act (BsUFA III)
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PDFFeb 01, 2022Ericka Nguyen
AAM Testimony Before Subcommittee on Health of the House Committee on Energy and Commerce
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Press Release Feb 2, 2022 Rachel Schwartz
AAM Statement on FDA User Fee Reauthorization

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