Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices; Notification of Public Meeting; Request for Comments

摘要

The Food and Drug Administration (FDA or Agency) is announcing a public meeting regarding FDA's implementation of Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA), which provides FDA with important new authorities to help it better protect the integrity of the drug supply chain. In addition to providing a general overview of Title VII and FDA's approach to implementing these provisions, the meeting will give interested persons an opportunity to provide input that will assist FDA in the development of regulations implementing two sections of Title VII, which relate to standards for admission of imported drugs and commercial drug importers. Specifically, FDA is seeking information on the types of information that importers should be required to provide under Title VII as a condition of admission. FDA is also seeking information regarding registration requirements for commercial drug importers and good importer practices to be established under Title VII.