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The FDA’s ad police warned a Campbell, Calif.-based company to stop claiming that its prescription diet pill can help patients lose weight three times faster than diet and exercise alone. Read More
Drug sponsors should “be careful” to make sure they’re properly screening treatments for nonalcoholic steatohepatitis (NASH) compensated cirrhosis patients for Phase 3 clinical trials , the FDA says in a new draft guidance issued Friday. Read More
Insys Therapeutics bribed doctors to prescribe its fentanyl spray, the company admitted as part of a $225 million settlement with the U.S. government, the Department of Justice announced. Read More
Drug sponsors should think about loosening up their exclusion criteria—especially when recruiting for later stage trials, the FDA says in new draft guidance document published Thursday. Read More