Category Archives: Regulatory

Food and Drug Administration Sends Letter to Biosense Technologies Regarding Urinalysis Phone App

After months of complaints from experts that the uCheck app is a medical device that failed to seek FDA approval, the U.S. Food and Drug Administration send a letter this week to Biosense Technologies, the maker of uChek smartphone-enabled unrinanalysis system instructing it to seek 510(k) clearance of its mobile medical application or to convince the FDA that such clearance is not necessary. James Woods a deputy director with the FDA, stated in the letter, “Please note that though the types of urinalysis dipsticks…

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BIVIGAM Recall

On April 2, 2013, the FDA issued an urgent recall for BIVIGAM Immune Globulin Intravenous, 10 percent liquid, 100 mL sterile vial due to visible particles observed in the liquid.  The recalled products are from lot# 120016 with an expiration date of March 31, 2014.  BIVIGAM is made by Biotest Pharmaceuticals and is used to treat primary immune deficiency.…

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Food & Drug Administration Admits It Could

Food & Drug Administration (FDA) Commissioner Margaret Hamburg testified before the U.S. House Energy and Commerce Committee’s Oversight panel about the agency’s actions leading up to the outbreak of meningitis that was linked to a compounding pharmacy last year and admitted that she regretted that the FDA did not do more and was not more directly engaged. She also acknowledged that the FDA had stopped conducting routine inspections of compounders as it developed a guidance documents for their regulation.  The FDA had stopped inspections because…

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Food & Drug Administration – Only 113 Characters Left In the Tweet

The FDA is on its way to regulating social media and its use by pharmaceutical companies.  By July 2014, the FDA must publish its guidelines for social media use. The FDA is faced with issuing guidelines on the appropriateness of tweeting.  A 140 character tweet is likely not long enough to include all of the necessary information such as risks and side effects.  Thomas Abrams, director of the FDA’s Office of Prescription Drug Promotion supports pharmaceutical companies promoting their products on Twitter if they can…

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