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“Gilead bore the risk and the vast majority of the cost of research and clinical studies to demonstrate Truvada’s efficacy and safety as part of combination HIV therapy,” O’Day told the panel. Read More
A federal judge has ordered a Texas drug compounder to cease all operations after failing to respond to warnings from the FDA about insanitary conditions. Read More
The FDA released its spring unified agenda on Wednesday for upcoming proposed and final rulemakings. Here are significant planned FDA actions for drugmakers listed for the first time: Read More
OTC monograph reform “remains a top priority” for the FDA, Lauren Silvis, chief of staff at the FDA’s Office of the Commissioner, said at a Consumer Healthcare Products Association meeting in Rockville, Maryland on Tuesday. Read More
Science has advanced enough that biosimilar sponsors can make a strong case for their product’s similarities to a reference product, but it’s going to be “critical” that sponsors understand the limits of their analytics, the FDA says in a new draft guidance document issued Tuesday. Read More