Drug Approval Process (GDUFA/BsUFA) | Association for Accessible Medicines

Drug Approval Process (GDUFA/BsUFA)

Resources

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.

PDFJul 24, 2017Erica Klinger
Rx Solutions Fact Sheet - GDUFA
Download |
PDFJul 18, 2018Tony Kurilla
AAM Statement on FDA’s Biosimilars Action Plan
Download |
PDFSep 11, 2018Christina Girardi
Update on GDUFA and BsUDA User Fees
Download |
Press Release Jul 12, 2017 Erica Klinger
AAM Applauds House Passage of FDA User Fee Reauthorization

Association for Accessible Medicines

202.249.7100

Sign-up for Updates

Receive relevant industry news, event information and the latest resources on biosimilars and generic medicines.

Stay Connected

For the latest updates, follow us on social media.