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Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes. Read More
A federal judge has signed off on a Justice Department-backed consent decree for a permanent injunction against Texas compounder Downing Labs. Read More
Lawmakers grilled FDA interim Commissioner Stephen Ostroff during a budget appropriations subcommittee hearing Thursday over the agency’s request for $5.1 billion for fiscal 2017. Read More
Pay-for-delay deals don’t have to be in cash form for them to be at risk of an antitrust suit, according to a recent federal appellate panel ruling. Read More
The Senate was urged Thursday to permanently reauthorize the Creating Hope Act, which would provide market incentives to pharmaceutical companies to develop drugs for pediatric rare diseases, ahead of a March 9 markup of the bill by the Senate HELP Committee. Read More
A year after announcing his Precision Medicine Initiative, President Barack Obama has outlined progress on the project, which aims to accelerate personalized medicine. Read More