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BIO Comments on Safety Labeling Changes and Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act

April 15, 2019

BIO submitted comments on the Food and Drug Administration (FDA)’s request for comments on safety labeling changes and implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA’s statements and estimates refer exclusively to electronic labeling (e-Labeling). This implies FDA’s recognition that electronic labeling is the most accessible, expedient, efficient, and thus, preferred method of providing labeling updates, particularly in the context of safety labeling changes which are deemed critical to a product’s safe use. However, the failure to capture or mention the significant burdens incumbent on sponsors in the context of paper labeling renders the AICA activity incomplete and potentially ineffective. 

Accordingly, BIO’s comments provide additional context around the burdens associated with continued requirements for paper labeling, as well as a description of some of the public health benefits provided by e-labeling.

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BIO Comments AICA Safety Labeling Changes-Implementation Of Section 505(o)(4) Of The Federal Food Drug And Cosmetic Act FDA–2018-N-4735
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