FDA May Refuse Drug Imports From Austrian Novartis Facility
The Food and Drug Administration may refuse entry to drug products manufactured at Novartis’ Ebewe Pharma facility in Austria, alleging that a drug produced at the facility is unapproved for U.S. distribution. According to the FDA warning letter, Novartis distributed…
Sign up for a free preview to unlock the rest of this article
Timely, relevant coverage of court proceedings and agency rulings involving tariffs, classification, valuation, origin and antidumping and countervailing duties. Each day, Trade Law Daily subscribers receive a daily headline email, in-depth PDF edition and access to all relevant documents via our trade law source document library and website.
the drug without the required FDA marketing application. The agency also alleged violations of current good manufacturing practice requirements at the facility.