High-Risk Drug Imports To Be Delayed, FDA PREDICTs; Focus On Data Quality Can Avoid New 20 Percent Dragnet
An FDA information technology system designed to identify high-risk imports for possible inspection should speed U.S. entry for about 80 percent of FDA-regulated products coming into the country
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An initial look at data from the first year of the import screening system’s full operation finds PREDICT is effective in directing FDA inspectors to high-risk products, Deputy Associate Commissioner for Regulatory Affairs Steve Solomon says.
FDA Counterfeit Screening Tool Gets Field Test In Ghana; Corning Prepares Device For Mass Production
FDA currently employs the CD3 in its laboratories and at a number of international mail facilities and other points of entry to the U.S. to screen cosmetics, foods, medical devices and cigarettes, as well as drugs.
FDA's PREDICT system should enable the agency to comply with the intent, if not the particulars, of a House Appropriations Committee suggestion to facilitate entry into the United States of goods that pose little risk.