Services to Ease FDA Regulatory Compliance

self identification for FY 2018




FDA’s self identification period for fiscal year 2018  starts from 1st May 2017 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 2017. 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) 2018.


The FY 2018 generic drug facility self-identification open reporting period will begin on May 1, 2017, and run until June 1, 2017.”

We at  Pragmatic  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.

Translate »