Before the Food and Drug Administration: Comments of the Wage and Price Stability

by Dianne Levine on November 3, 1976
by Dianne Levine

 

The Council on Wage and Price Stability (Council) hereby submits its comments on the proposal of the Commissioner of Food and 

 

 

 

Drugs (FDA) to require new labels directed to patients on all estrogens for general use. The proposed requirements describe the kinds of statements that must be included in the label and the manner in which such labels are to be made available to the patient. The proposed regulation was published in the September 29, 1976 issue of the Federal Register (40 FR 52172), with an invitation for interested parties to submit comments by November 29, 1976.

The Council supports, in principle, a policy requiring manufacturers of drugs with a significant risk of serious side-effects to explain fully that risk on a label directed to the patient.

 

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