FDA’s self identification period for fiscal year 2019 starts from 1st May 2019 and all the facilities involved in generic drug submission are required to submit, update or re-confirm the self identification on or before 1st June 2019. CDER has started to send email with below content to all the facilities who have self identified in the previous year.
“Submit, Update, or Reconfirm Self-Identification Information to the Food and Drug Administration (FDA) for Fiscal Year (FY) 2019.
The FY 2019 generic drug facility self-identification open reporting period will begin on May 1, 2019, and run until June 1, 2019.”
We at FDAbasics offer complete assistance for GDUFA self identification submission to FDA. It is important to understand the classification of your facility whether its CMO or non CMO based which GDUFA fees are applicable.
If you need any assistance on GDUFA self-identification or if you have any questions please contact us.