"IMPORT FOR EXPORT" PROVISIONS OF EXPORT LAW MAY BE EXPANDED TO INCLUDE UNAPPROVED FINISHED DEVICES; "TRANSSHIPMENT" OF EXPORTS ALSO MAY BE ADDRESSED
This article was originally published in The Gray Sheet
Executive SummaryCongress may expand the "import for export" provisions of "The FDA Export Reform and Enhancement Act of 1996" to allow importation into the U.S. of unapproved finished devices intended for subsequent export, congressional staffers told attendees at a June 27 Food and Drug Law Institute conference in Washington, D.C. The current provisions, which were signed into law April 26, allow manufacturers to import unapproved "components" for assembly of finished devices meant for export.
You may also be interested in...
Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.
Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza
The latest drug development news and highlights from our US FDA Performance Tracker.
Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.