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WSJ: U.S. Wockhardt plant accused of employing an unapproved method to test drug quality

BY Michael Johnsen

NEW DELHI — Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.

Citing inspection documents released on the FDA website, the WSJ reported that Wockhardt employees used "trial injections," in which early sample tests of the drugs were taken before the official recorded quality test.

The Morton Grove plant produces roughly half of the drugs the company sells in the United States, according to the WSJ report.

According to the FDA’s website, FDA regulators found appropriate controls were not exercised over computers or related systems at the Chicago plant, meaning any user could change or delete data stored on them. Further, staff was not properly trained under current good manufacturing practices, the website showed. In addition, the FDA’s investigator observed an employee entering the manufacturing area of the plant without washing and sanitising his hands.

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Apple unveils greater health app functionality with release of iOS 8

BY Michael Johnsen

SAN FRANCISCO –Along with Apple’s release of iOS 8 on Monday, the company introduced an entirely new Health app that provides a clear overview of a user’s health and fitness data.

The new Health app gathers the information the user chooses from various health apps and fitness devices, and provides them with a clear and current overview in one place, Apple announced. iOS 8 offers developers the ability for health and fitness apps to communicate with each other through a new tool for developers called HealthKit. With the user’s permission, each app can use specific information from other apps to provide a more comprehensive way to manage your health and fitness.

For example, the Nike+ apps using NikeFuel will be able to pull in other key HealthKit metrics, such as sleep and nutrition, to build a custom user profile and improve athletic performance. Or data from a blood pressure app can be automatically shared with the doctor.

Users will also be able to create an emergency card with important health information — for example blood type or allergies — that’s accessible from the lock screen.

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Rite Aid partners with AFA on offering memory screenings

BY Michael Johnsen

NEW YORK – In an effort to spotlight the importance of early detection of memory problems, the Alzheimer’s Foundation of America on Monday announced it is collaborating with Rite Aid to offer free, confidential memory screenings at all Rite Aid stores on June 4, from 10 a.m. to 2 p.m.

The screenings will be available during the chain’s monthly wellness65+ Wednesday event, which is designed to help seniors better enjoy their everyday life by proactively managing their health.

Rite Aid pharmacists will administer the paper screenings, which consist of a series of questions and tasks and last approximately five to 10 minutes. While screening results are not a diagnosis, they can indicate whether someone should follow up with a primary care physician or other healthcare professional for a thorough medical evaluation. Educational materials from AFA about brain health will also be available to customers.

"Rite Aid is providing an invaluable service by offering memory screenings in convenient neighborhood locations," said Charles Fuschillo, Jr., AFA’s CEO. "Its participation sends the message that it’s OK for people to talk about memory concerns and to be proactive about brain health."

The collaboration is part of AFA’s new initiative, Community Memory Screening and Awareness-Raising Education. AFA C.A.R.E.S. builds on AFA’s National Memory Screening Day-held annually since 2003-by expanding the availability of free, confidential memory screenings from one designated date to various times throughout the year at community sites across the country.

Rite Aid’s upcoming screening event comes on the heels of the entire chain’s participation in National Memory Screening Day in 2013.

AFA suggests memory screenings for people concerned about memory loss or experiencing warning signs of dementia, whose family and friends have noticed changes in them or who believe they are at risk due to a family history of Alzheimer’s disease or a related illness. Screenings also are appropriate for anyone who does not have a concern right now, but who wants to see how their memory is now and for future comparisons.

Some memory problems can be readily treated, such as those caused by vitamin deficiencies or thyroid problems. Other memory problems might result from causes that are not currently reversible, such as Alzheimer’s disease.

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