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The FDA handed SSM Health Care a warning letter for GMP deficiencies in compounding sterile drug products as well as failure to follow 503B conditions for outsourcing facilities at its Fenton, Mo., facility. Read More
Novartis has agreed to pay a tentative settlement of $390 million in a whistleblower’s lawsuit alleging the company received kickbacks from pharmacies to promote products, ending a four-year-old case. Read More
The FDA’s program alignment will see district offices and laboratories focus only on one category of products, primarily designated by geographic location and the types of industries that surround those locations, FDA Acting Commissioner Stephen Ostroff said. Read More
Drugmakers won a victory on Monday when the Senate approved by unanimous consent an amended bill that would extend exclusivity periods for new drugs by changing the date on which they are considered to have been approved from FDA sign-off to when the DEA schedules them. Read More
Democratic presidential candidate Hillary Clinton joined the growing chorus of lawmakers and others outraged over Turing Pharmaceuticals’ price hike on Daraprim, pressing the FDA and FTC on Oct. 19 to broaden access to less expensive drugs. Read More
In an effort to ease a major generics approval backlog, the FDA is advising generic drugmakers and regulators on how best to streamline ANDAs of varying strengths into a single application. Read More
Swiss-based Helsinn Healthcare has settled patent litigation with Dr. Reddy’s Laboratories, allowing the Indian genericsmaker to sell a generic version of the anti-nausea injection Aloxi starting in 2018. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that the drug bound to about half of the oral medications tested. Read More
Sun Pharmaceuticals has quietly dropped an appeal of a lawsuit challenging the FDA’s authority to revoke the tentative approval of two generics made by its Ranbaxy subsidiary. Read More