FDA to hold hearings on pediatric OTC medicines
ROCKVILLE, Md. The Food and Drug Administration on Friday posted notice for a public hearing to be held Oct. 2 to discuss again the use of over-the-counter medications in pediatric populations.
That’s good news for suppliers and retailers in the cough/cold space, as it lifts any consternation that an FDA decision on whether or not cough/cold medicines are appropriate for children under the age of six is imminent. Many category managers were concerned that if the FDA were leaning toward possibly pulling cough/cold products marketed for use in children under the age of six, that the agency may decide to announced that decision just as new cough/cold planograms for the 2008/2009 season were to be implemented in September.
And while the FDA can take many months to make a decision on an issue around which they’ve requested public input, last year’s decision to officially ban marketing cough/cold products to children under the age of two came in January 2008, just as the cough/cold season was beginning to take off, following the initial Citizen’s Petition hearing in mid-October 2007.
The public hearing is to be held at the Sheraton Washington North Hotel in Beltsville, Md., from 8 a.m. to 5 p.m.
FDA grants clearance to Home Diagnostics for pair of glucose meters
FORT LAUDERDALE, Fla. Home Diagnostics on Wednesday received 510(k) clearance from the Food and Drug Administration for the world’s smallest blood glucose meter, TRUE2go’, and for TRUEresult’, the company’s latest advanced performance, no-coding meter for at-home testing.
“Over the past three years we made capital investments in excess of $15 million in order to bring the TRUE2go and TRUEresult to market and are pleased to have FDA clearance for the new products,” stated Richard Damron, Jr., president and chief executive officer of Home Diagnostics. “Our new product platform is designed to fit people’s needs whether they are testing at home or on-the-go, making it easier for them to test accurately and quickly.”
TRUE2go is small enough to twist and attach to the top of a vial of test strips, offering patients a higher level of convenience for on-the-go testing.
Both new meters are compatible with the company’s new TRUEtest platform of blood glucose test strips featuring the company’s patent-pending GoldSensor’ laser accuracy and TRUEfill’ beveled tip. These features ensure highly accurate test results and first test success by allowing for greater sampling precision and consistency.
The new TRUE systems feature no-coding technology that simplifies blood glucose testing by eliminating the need for users to code the meter with each new box of test strips. Both TRUE2go and TRUEresult deliver results in as fast as four seconds using 0.5 microliters of blood.
TRUE2go and TRUEresult will be available in the fourth quarter of this year.
Study shows teens at risk of hypertension due to lack of sleep
NEW YORK A new study shows that teenagers who don’t get enough sleep face the risk of elevated blood pressure.
The study examined 238 boys and girls aged 13 to 16 and found that 11 percent of them slept less than 6.5 hours a night, while 26 percent of them woke up frequently, a phenomenon called low sleep efficiency. One out of every seven of the teenagers had high blood pressure, while those with low sleep efficiency increased their risk of high blood pressure threefold.
The study appears in the Aug. 19 issue of the journal Circulation.