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The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. Read More
The FDA cited a Montreal drugmaker for refusing to allow an FDA inspector to take photographs during an inspection — and said that alone can lead to a finding that products are adulterated. Read More
The Ohio Taxpayers for Lower Drug Prices advocacy group accuses drugmakers of making donations aimed at influencing an election, meeting the definition of a political action committee. Read More