As required by Generic Drug User fee act FDA self identification period for fiscal year 2016 starts on May 1s 2015, and companies can self-identify their facilities till June 1st ,2015.
Companies who are into generic drug Manufacturing, Testing. Packaging or Conducts Bioequivalence /Bio analytical study are required to self-identify with FDA by providing the information type of operation they perform such as manufacturing, API manufacturing , testing, etc..
Self-identification process helps FDA to calculate the estimated GDUFA fees for upcoming fiscal year.
Not all the facilities who self-identify are not required to pay the GDUFA fees, only facilities who manufacture or intend to manufacture the finished product or API are required to pay the GDUFA fees.
Failure to self-identification is violation of federal law and may results disciplinary action by FDA.
Tobias Systems can assist companies to self-identify your facilities at the lowest fees and also provide whether self-identification for your facility is required or not.
If you have any questions on self-identification please write to us .