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Category: Pharmaceutical Industry

Dec
07

21st Century Cures Act Calls for 21st Century Recall Preparation

The 21st Century Cures Act has cleared a major Senate hurdle and is expected to be signed into law by President Obama. Among other provisions, the bill will fast-track the approval process for certain drugs and medical devices. The $6.

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Nov
18

The “One Click Rule” …Coming to a Website Near You?

Anyone who has ever had a prescription filled knows these drugs come with a lengthy list of both benefits and risks that could rival many peer-reviewed journals. But of course, that isn’t the only place both types of information must be listed. Any promotion of a drug’s claims must also include a “fair balance” of risk information as well. The requirement has made many forms of online marketing difficult due to lack of space. Now, the Food and Drug Administration (FDA) is

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Oct
26

Counterfeit Drugs Online: A Threat to People and Brands

With the rise of online commerce, countries all over the world are affected by counterfeit pharmaceuticals. Despite their stringent regulations, none of them are immune to product fakes. Because more and more consumers can connect with false suppliers over the internet, it’s crucial for pharmaceutical companies to safeguard themselves and their brand against the consequences of counterfeits.

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Jun
07

Message on a Bottle: Mislabeling and Other Causes of Pharma Recalls

Recent recall trends give pharmaceutical companies reason to be optimistic. As outlined in our Q1 2016 Recall Index, the number of units recalled took a drastic drop during the first part of the year – to their second lowest level in a decade. In other promising news, more than half of those units were considered a Class III recall, the least hazardous classification.

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Apr
28

Biosimilar Development Necessitates Recall Readiness

In the last few months, the Food and Drug Administration (FDA) has not only released new guidance related to biosimilar products, it’s approved the first biosimilar product for human use. Biosimilars were a focus of the FDA recently, with an estimated $81.

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