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The FDA needs more data on the likely impact on patients before it introduces tighter controls on high-strength opioids and doses for outpatient settings, the agency heard in a two-day public meeting. Read More
A Florida drug company at the heart of ongoing disputes over the price of life-saving drugs has doubled down, bringing a federal lawsuit against the FDA for the agency’s alleged end-run around the drug company’s commercial rights. Read More
The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers to get on the right side of the law. Read More
The latest suit alleges that Mallinckrodt and Questcor—a company that Mallinckrodt acquired in 2014—used a charitable foundation to support “free” prescriptions for its HP Acthar gel. Read More
Grassley said that he’s confident that a package of bills will get to the Senate floor this year that will bring some daylight into the nation’s drug pricing regimes. Read More