FDA Clarifies Rationale for Refusing ANDAs for New Drug Strengths

August 25, 2016

Drugmakers submitting ANDAs for new drug strengths face FDA refusals due to insufficient justifications for impurities in the products, the agency says.

In a final guidance released Wednesday, the FDA offers generics drugmakers advice largely consistent with recommendations included in a 2014 draft version of the document.

The one exception is that the FDA omits the term “proper” in the latest iteration to underscore that it does not address the technical review of impurity limit justifications in ANDAs. Industry feedback on the draft guidance prompted the revision, the FDA says.

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