OTC Vaginal pH Tests Should Include Educational Labeling, Panel Says
This article was originally published in The Gray Sheet
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.
You may also be interested in...
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.
Oxford University/AstraZeneca’s COVID-19 vaccine cuts the spread of the virus by 60%, apart from having 70% efficacy in reducing infections in vaccinated individuals. While that is good news for their Indian partner, Serum Institute, the 90% efficacy shown in a subset due to a dosing error causes a dilemma.
After announcing positive topline Phase II results for its Alzheimer’s candidate late last year, Korea's GemVax releases additional data showing significant improvement in secondary outcomes, further raising expectations for the novel peptide drug.