On August 27, 2015, the Food and Drug Administration issued a guidance that establishes a naming convention for biologicals. Included among these biologicals are biosimilar products. The issuing of this guidance serves to resolve debates on how such compounds should be named.

According to the guidance, biosimilar products will share the same nonproprietary name as the biologics to which they are similar.

However, a four-letter suffix will be used to differentiate a biologic from its corresponding biosimilar. By using this suffix, the Food and Drug Administration hopes to prevent substitution of medications that are not biosimilar by pharmacists, thereby decreasing errors. The Food and Drug Administration also hopes to track the use of these biosimilars and monitor them more effectively.

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September 18, 2015

The FDA and Nanotechnology

Nanotechnology is one of the newest areas in the pharmaceutical industry.

Although nanotechnology has shown promise in increasing the bioavailability of pharmaceuticals, the clarity of radiographic procedures, and the effectiveness of targeted therapies, the Food and Drug Administration considers the changes in the products manufactured with nanotechnology to be in need of further assessment to determine safety, efficacy, and bioavailability compared with their larger-molecule compounds.

As such, pharmaceutical companies should understand the Food and Drug Administration’s current approach to nanotechnology and the guidances that they have issued on the matter.

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Personalized medicine has attracted much interest within the healthcare community during recent years. More physicians are striving to customize their medical treatments to their patients’ unique genetic makeup and circumstances.

However, personalized medicine poses a number of regulatory challenges. As such, pharmaceutical executives should understand these challenges and how they affect the industry.

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In addition to approving pharmaceuticals and biologics, the Food and Drug Administration is responsible for determining whether an approved treatment is safe.

As such, they require the companies that manufacture these treatments to report on adverse events that patients experience after a treatment is approved. Pharmaceutical companies should understand the appropriate mechanisms to submit these reports.

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