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The drug industry is asking the FDA for more clarity around whether or not natural histories should be included in rare disease trials—and two of the nation’s largest drug trade groups appear to be at odds over the issue. Read More
The Trump administration has ordered federal agencies—including the FDA—to submit all pending guidance documents to the White House budget office, a move that some experts say could stall drug policy changes. Read More
British Prime Minister Theresa May has won a further delay from European leaders until Oct. 31 on the UK’s exit from the EU, leaving drugmakers no clearer about the ultimate impact of Brexit on the supply chain. Read More
The FDA issued a final rule on Thursday requiring OTC sanitizers with certain active ingredients to seek approval under an NDA or ANDA as a new drug. Read More
Gottlieb sought during his two-year tenure at the FDA to address the issue by indirect means, such as by speeding up reviews of generics to spur competition. Read More