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Senators Call on FDA to Allow Certain Canadian Drug Imports
By Zachary Brennan, Regulatory Affairs Professionals Society (RAPS) Nov 24, 2015
The US Food and Drug Administration (FDA) should allow the importation of pharmaceutical products from Canada if they meet certain stipulations, Sens. Chuck Grassley (R-IA) and John McCain (R-AZ) wrote in a letter to Health and Human Services (HHS) Secretary Sylvia Burwell. The senators call on FDA to “immediately” certify the importation of prescription drugs if they are off patent and are no longer marketed by the drug developer, if there are “significant and unexplained” price increases, if no direct competitor product is currently marketed and the introduction of a new drug will benefit US consumers, or if the drug is “produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the United States.”
Read Full Article on Regulatory Affairs Professionals Society (RAPS) »