TGA Calls for Comments on Proposed Boxed Warning Requirements

Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention.

The agency says boxed warnings can be based on clinical data, but non-clinical data sources may be used in certain circumstances.

The clinical data can originate from market authorization studies and post-market sources, and, in certain settings, from off-label use of the medication. Data may be used from additional studies or independent sources “if sufficiently robust,” the agency said.