FDA Strikes Certain Data Requirements for Imported Products in Final Rule

Taking into account industry criticism, the FDA has loosened the data requirements that drugmakers will have to meet to determine the admissibility of imports entering the U.S.

In a final rule, the FDA said it no longer expects drugmakers to submit information on the total value of an entry or the total value of the articles in each import line; on the quantity of the product in each import line, including each layer of packaging; or the name, telephone, and email address of any persons related to the importation.

In a little more than a decade, the volume of FDA-regulated imports entering the country rose from 6 million to 35 million, said Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.