Industry Concerned About Proposed Drug Label Changes in Australia

Thursday, January 29, 2015

Source: FDA News

Drugmakers and industry groups are urging regulators in Australia to abandon proposed new requirements that call for larger type on drug labels and for labels to be made and applied so that they cannot be damaged by opening a product.

The changes would require drugmakers to make major modifications to label design, packaging configurations and packaging processes, all of which are unreasonable costs to place on the industry, Medicines Australia says.

The input comes in response to an August 2014 solicitation by the Therapeutic Goods Administration for comments on proposed revisions to the general labeling requirements for drugs.

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