We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
An Indianapolis jury convicted the former CEO of a Noblesville, Indiana drug compounder of conspiracy to defraud the FDA and multiple counts of drug adulteration—including some over-potent children’s drugs shipped to hospitals. Read More
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