Hormone Therapy Class Labeling Uses Wyeth Template; Appeals Due By March
Executive Summary
Sponsors of hormone replacement therapies have two months to pull together data to justify exemptions to FDA's proposed class labeling incorporating risk information from the Women's Health Initiative
You may also be interested in...
Premarin WHI Results May Mean Additional Labeling Changes, FDA Says
FDA may request additional changes to the labeling of hormone replacement therapies based on the findings from the terminated Premarin arm of the Women's Health Initiative
Premarin WHI Results May Mean Additional Labeling Changes, FDA Says
FDA may request additional changes to the labeling of hormone replacement therapies based on the findings from the terminated Premarin arm of the Women's Health Initiative
Berlex Climara Pro Triglyceride Effect Is Point Of Difference For HRT Patch
Berlex Labs can highlight Climara Pro's effect on triglycerides as one point of differentiation in marketing the transdermal hormone therapy product