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A Colorado dietary supplement manufacturer wrongfully included potentially harmful ephedrine alkaloids in one of its products and made improper claims for drug-like effects from others, the FDA said in a warning letter. Read More
A group of Iraq War veterans and their families filed a lawsuit this week accusing several drugmakers of contributing to servicemembers’ deaths by indirectly funding militias in Iraq. Read More
The FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA submissions. Read More