FDA’s Foreign Supplier rule has an especially ambitious agenda
date:May 31, 2016
erseas, and can only do so much with its current budget and staffing levels.
Asked how the agency plans to enforce the rule, Freedman responded this way:
First, we plan to provide educational materials to industry (e.g. public meetings, webpages). After the compliance dates, the FDA will begin reviewing the records of importers to determine compliance with the FSVP regulation. If the FDA determines, based on the review, that the importer is not in compliance with the applicable FSVP requir
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