US FDA plans sNDA amendments

The US Food and Drug Administration is proposing to amend its regulations regarding changes to an approved New Drug Application, Biologics License Application or medical device Pre-market Approval application to codify its longstanding view on when a change to the labeling of any of these products made in advance of the agency's review of such change.

The FDA says it is proposing to reaffirm its position that a supplemental application submitted under those provisions is appropriate to amend the labeling for an approved product only to reflect newly-acquired information, as well as to clarify that such a supplemental filing may be used to add or strengthen a contraindication, warning, precaution or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic or device. The amendments proposed are intended to reflect the agency's existing practices with respect to supplemental applications submitted to it.

The agency has requested that both written and electronic comments on the amendments proposed should be submitted by March 17.