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The U.S. District Court for the District of New Jersey issued a permanent injunction barring online distributor Just Enhance from illegally selling sexual enhancement products on more than 100 websites. Read More
In the latest CMS move aimed at reducing drug prices, Administrator Seema Verma released new guidance on how Part D plan sponsors can negotiate formulary coverage based on specific indications starting in 2020. Read More
FDA Commissioner Scott Gottlieb announced more recalls Thursday in the FDA’s ongoing investigation into contaminated valsartan products and said the impurity may be a byproduct of the API manufacturing process. Read More
FDA Commissioner Scott Gottlieb Wednesday said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new opioid alternatives and improve benefit and risk assessments of new opioid drugs in the works. Read More
Drug sponsors wishing to take part in the FDA’s pilot meeting program to discuss complex innovative trial designs (CIDs) with agency staff may now file meeting requests. Read More