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Swiss Precision Diagnostics showcases latest in home pregnancy test technology at OBGYN meeting

BY Michael Johnsen

NEW ORLEANS — Swiss Precision Diagnostics on Monday unveiled the new Clearblue Advanced Pregnancy Test with Weeks Estimator at the 61st Annual Clinical Meeting of the American Congress of Obstetricians and Gynecologists here. The latest home pregnancy test kit not only tells a woman if she is pregnant but also estimates the number of weeks since ovulation. 

“Confirming pregnancy is a life-changing moment in any woman’s life, and it sparks so many immediate questions like when did I get pregnant? That’s why we are thrilled to be able to bring the new Clearblue Advanced Pregnancy Test with Weeks Estimator to women in the United States,” stated Kirsten Suarez, Clearblue brand manager. “This test was created based on years of qualitative and quantitative consumer research and a clear understanding that a woman wants as much information as possible as soon as she receives a positive result. The Clearblue Advanced Pregnancy Test with Weeks Estimator gives her more information right at the beginning of this new phase in her pregnancy journey than she’s ever had before.”

Currently, the majority of physicians estimate weeks of pregnancy using a formula based on a woman’s last menstrual period. However, one in six women do not have a last menstrual period recorded and approximately 70% are uncertain of their last menstrual period.  

The Clearblue Advanced Pregnancy Test with Weeks Estimator uses technology that takes two measurements instead of one and not only gives an accurate pregnancy result but also estimates the number of weeks since ovulation. The test is more than 99% accurate in detecting pregnancy from the day of the expected period, and it is approximately 93% accurate in estimating how many weeks based on time since ovulation.

All home pregnancy tests are designed to detect the hormone hCG in urine to determine pregnancy. However, the Clearblue Advanced Pregnancy Test with Weeks Estimator also measures the concentration of hCG, which helps estimate when fertilization occurred. If the test is positive, ‘Pregnant’ will be clearly indicated in words on the display along with an estimate of how many weeks have occurred since ovulation: 1-2 weeks, 2-3 weeks or 3+ weeks.  

The Clearblue Advanced Pregnancy Test with Weeks Estimator will be available in stores and online in September 2013, the company noted.


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FDA Law Blog: Recent Plan B One Step approval may reignite simultaneous Rx-OTC debate

BY Michael Johnsen

WASHINGTON — The Food and Drug Administration may soon find itself in another Plan-B-generated quandary — the complications around granting a three-year marketing exclusivity for a medicine that is both prescription-only and over-the-counter, according to an FDA Law Blog posted Sunday by Hyman, Phelps & McNamara

At issue is the granting of three-year marketing exclusivity on an OTC new drug application when approvals of abbreviated new drug applications for prescription-only versions of the same medicine have already been approved. 

"It is undisputed that, based on FDA’s representations regarding the need for additional data to support approving Plan B One Step for use without a prescription by younger age groups, [Plan B One Step manufacturer] Teva conducted actual use studies that included participation by sufficient numbers of 15 and 16 year olds," wrote Kurt Karst, author of the blog.

That additional research was critical in the FDA’s approval of expanding OTC use to younger females, Karst noted. 

At question is whether or not the PLAN B One-Step NDA supplement approval "affects the approval status of generic versions of PLAN B One-Step approved under ANDAs," Karst wrote. "The NDA supplement approval seems to raise the thorny issue of simultaneous prescription and OTC marketing of the same drug," he noted. "We don’t have the answers to those questions, but resolution of whether there is a simultaneous prescription and OTC marketing issue in the first place, and then what to do about it if there is, might be an interesting side-show as the Second Circuit takes up Judge [Edward] Korman’s decision."

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New 31° Diamond Skincare Collection features microfine diamond powder

BY Antoinette Alexander

NEW YORK — Harnessing the power of the diamond is the new 31° Diamond Skincare Collection by Rene, a new cosmetics maker.
 
Each product within the collection contains microfine diamond powder that works to tame and heal common complexion problems, according to the company.
 
Get started on the pathway to better skin with the help of the 31° Diamond Detox Peeling Gel. Featuring the exfoliating and renewing properties of diamond powder, and the antioxidant rich and soothing qualities of berry extracts and flower essences, this peeling gel is designed to gently work to improve the texture of the skin for a glowing complexion.
 
The Sheer Coating Ampoule helps enhance the skin’s tone. It is enriched with diamond powder and ingredients such as hyaluronic acid, peptide, collagen, and vitamin B5 work to boost elasticity and hydration, lock in moisture, visibly fade spots and even out skin tone.
 
As for the name, the Rene 31° Diamond Skincare Collection alludes to the skin’s need for a constant temperature of 31° celsius or 87° fahrenheit, the company stated. One degree above and the skin starts to become stressed releasing oils and creating blemishes. Rene’s whole collection is dedicated to providing thermal protection by balancing the skin’s temperature for smooth and radiant looking skin.
 

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