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.
Download Full Comments Below
BIO Comments AICA Safety Labeling Changes-Implementation Of Section 505(o)(4) Of The Federal Food Drug And Cosmetic Act FDA–2018-N-4735
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
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.