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Drug Serialization Trends and Developments


The sale and use of counterfeit medicines pose a real and potent threat to global health and commerce. Over the past decade, the threat of counterfeit medicines has increased, with incidents of counterfeiting reported in 123 nations. One watchdog group documented 2,193 incidents of pharmaceutical crime in 2013 alone, representing almost a 9 percent increase from 2012. This rise can be attributed largely to the growing online pharmaceutical marketplace that enables counterfeit drugs to permeate households. Counterfeit pharmaceuticals often lack active ingredients, depriving the patient of the medication they need. Even worse, counterfeit drugs have been found to contain poisons such as arsenic, shoe polish, nickel, and leaded road paint. While many counterfeits reach patients through online markets, these falsified medications have also penetrated legal supply chains.
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In The Headlines

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The New Frontier of 3D Printing and Medical Device Approvals

Today, 3D printing technology produces objects of just about any shape from computerized models. Most medical device companies use this technology to preview products, but it can be used to create generally available surgical implants as well as highly customized implants that are intended for unique patients requiring special devices with specific dimensions and materials. These customized devices have amazing, life-saving applications beyond the typical prototypes created by 3D printers. They can be suited to a patient’s particular anatomy and include devices such as hearing aids, dental implants, titanium surgical implants, and even major tissue organs. These printing machines have created sustainable heart valves in emergent cases and can even be used in organ transplant cases, giving hope to patients waiting for donor organs.
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Topic of Discussion

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Lessons Learned – Important Takeaways From Recent Enforcement Actions in the Pharmaceutical Industry

U.S. Securities and Exchange Commission (SEC) Enforcement Chief Andrew Ceresney’s remarks at CBI’s recent Pharmaceutical Compliance Congress highlight some key learning points for those in the pharmaceutical industry. Perhaps most notable is the fact that Mr. Ceresney was at the conference at all.
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