FDA Import Alert: Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.

When evidence exists for the marketing or promotion of unapproved drugs to individuals residing in the United States, the products should be considered for detention without physical examination. 

Evidence of marketing or promotion may consist of information contained in: solicitations for mail orders; press releases; internet websites; advertising materials; label indications of US patents or patent applications; or other public announcements directed to persons residing in the U.S. *** Read More →