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As part of its ongoing enforcement efforts against drug compounders, the FDA plans to move the program’s base of operations from CDER’s Office of the Center Director to the Office of Compliance, Director Janet Woodcock announced Monday. Read More
Official Washington’s patience with the drug industry is wearing thin and the latest sign comes in a letter from eight Republican senators to PhRMA seeking answers—and not excuses—for rising drug prices. Read More
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nonalcoholic steatohepatitis (NASH) compensated cirrhosis patients for Phase 3 clinical trials , the FDA says in a new draft guidance issued Friday.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