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The FDA and other international regulators and law enforcement agencies have joined forces to crack down on illegal online drug distributors, requesting the suspension of 4,402 websites that sell illegal and potentially counterfeit products to U.S. consumers. Read More
An FDA advisory committee recommended the approval of Merck’s bezlotoxumab to prevent Clostridium difficile infection recurrence in patients 18 and older. Read More
The FDA has handed Boehringer Ingelheim a 10-observation Form 483 for delays with a field alert report, as well as sanitation and sterilization procedures at a site in Germany. Read More
The House Energy and Commerce Committee passed by a voice vote Wednesday a measure that would ensure tropical disease priority review vouchers are not issued to products with regulatory approval in other countries. Read More
The time and effort to collect the quality metrics dictated in the FDA’s draft guidance are about three times higher than the FDA’s original estimates. Read More
In stark contrast to comments from generic industry trade groups, a patient advocacy organization is calling for including more information in biosimilar product labeling. Read More