Femtek To Seek Estrogen Indication For pHEM-ALERT Vaginal pH Test
This article was originally published in The Gray Sheet
Executive Summary
Femtek, Inc. is hoping to build on the over-the-counter status of its pHEM-ALERT vaginal pH test by pursuing an expanded indication for the indirect measurement of estrogen levels in lieu of serum testing.
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Femtek To Seek Estrogen Indication For pHEM-ALERT Vaginal pH Test
Femtek, Inc. is hoping to build on the over-the-counter status of its pHEM-ALERT vaginal pH test by pursuing an expanded indication for the indirect measurement of estrogen levels in lieu of serum testing.
OTC Vaginal pH Tests Should Include Educational Labeling, Panel Says
Labeling on over-the-counter vaginal pH tests should serve as an educational tool, a majority of FDA's Clinical Chemistry and Clinical Toxicology Devices Panel agreed at a Dec. 7 meeting.