Drugs

Researchers Review Drug Anti-counterfeiting Safeguard

German researchers have developed an “on-dose marker technology” based on polyethylene glycols (PEGs), a commonly used pharma excipient, as a new approach to possibly thwart drug counterfeiters. Writing in the European Journal of Pharmaceutics and Biopharmaceutics (2/2016), the researchers describe a technique in which they incorporated combinations of PEGs within the coating of tablets to create a unique code that can be used to authenticate the dose using a liquid chromatography/mass spectrometry (LC-MS/MS) method, according to SecuringIndustry.com.

“Several batches of these PEGs, each batch being monodisperse with respect to its molecular weight, served as the basis for coding, and specific codes were 'written' into the coating of the drug product itself,” the researchers explain. The tamper-proof code only known to the manufacturer, and so each individual tablet becomes fully traceable, they note.

Current efforts to guard against counterfeit medicines often focus on serialization of the secondary packaging which — while providing a substantial improvement in patient safety — do not allow individual unit tracing, the report says. However, the PEG coding approach is limited to instances where PEGs are not present for formulation purposes as excipients.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome