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Carlton’s Dunwoody Pharmacy failed to establish a testing program, failed to prepare production records, used inadequate instruments, and violated labeling rules. Read More
Two AIDS patient advocacy groups urged New York Attorney General Eric Schneiderman — a frequent foe of anticompetitive behavior by drugmakers — to investigate potential pay-for-delay deals by Gilead. Read More
A District of Columbia federal court ruled Mylan Pharmaceuticals and two chemical companies must pay $67 million to Blue Cross Blue Shield of Massachusetts and three other insurers in a long-running suit that accused the companies of antitrust violations. Read More
The FDA outlined its procedures for conducting filing reviews of ANDA applications, detailing the standards agency staff will use to judge whether a submission is sufficiently complete before beginning a formal evaluation. Read More
Arizona joined the growing number of states filing lawsuits alleging marketing fraud by opioid manufacturers, as Attorney General Mark Brnovich filed suit against Insys Therapeutics and three doctors for allegedly being part of a fraudulent and misleading marketing effort for Susys (fentanyl). Read More
The FDA took its first step in requiring sponsors to submit REMS documents electronically, publishing a draft guidance that outlines the specifications. Read More