New FDA Guidance:Self-Identification of Generic Drug Facilities, Sites, and Organizations
FDA is issuing this guidance to help human generic drug facilities, sites, and organizations meet the self-identification requirement.
Topics discussed in this guidance include:
? which types of generic facilities, sites, and organizations are required to self-identify;
? what information is requested;
? what technical standards are to be used for electronically submitting the requested information;
? the penalty for failing to self-identify.
This guidance also explains generally which types of generic facilities, sites, and organizations will be required to pay user fees.