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Expert Articles

As patents for older biologicals expire, a new market for biosimilars has opened.  This new market allows manufacturers to market less expensive alternatives for patients. Despite this, the Food and Drug Administration (FDA) had done little to establish a mechanism for biosimilar approval until relatively recently, and only a few biosimilars have been approved in […]

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The Anatomy of a Mock Inspection Introduction Inspections by the Food and Drug Administration are challenging. If the company fails, the Food and Drug Administration can issue them a warning letter or, in extreme cases, shut down the company’s operations entirely. Because the consequences of noncompliance are serious, many executives would like to know where […]

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The Food and Drug Administration has made a recommendation that transvaginal mesh be reclassified as a Class III device.   Previously, transvaginal mesh had been classified as a Class II device and was required to go through the 510(k) process; however, under the new regulations, it would require premarket approval. This reclassification is the result of […]

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