Zdrowie i gospodarka · 18/06/2024

FDA Releases Final Guidance on Facility Readiness for ANDA Submissions Under GDUFA

The FDA has released a final guidance for industry on facility readiness for original abbreviated new drug applications (ANDAs), incorporating a program enhancement agreed upon by the Agency and industry as part of the Generic Drug User Fee Amendments (GDUFA) reauthorization. The guidance finalizes a draft released on October 7, 2022, and provides information on how the FDA will use facility readiness information to set a goal date for ANDA submissions.