FDA posts draft guidances describing GDUFA performance metrics and associated webinars

FDA published notices in the Federal Register announcing the availability of two draft guidances for industry:

• Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA, and
• Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA

These draft guidances are intended to assist applicants preparing to submit amendments to ANDAs, prior approval supplements, and amendments to prior approval supplements under the Federal Food, Drug, and Cosmetic Act, by explaining how the GDUFA performance metrics apply to these submissions.

Pre-recorded webinars explaining these guidances are available at:

• Abbreviated New Drug Application (ANDA) Submissions – Prior Approval Supplements Under GDUFA
  • Adobe Connect Link: https://collaboration.fda.gov/p98ulfi2wfd/
• Abbreviated New Drug Application (ANDA) Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA
  • Adobe Connect Link: https://collaboration.fda.gov/p2ehqu6hu81/

Submit electronic comments on the draft guidances to www.regulations.gov