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The U.S. Attorney for the Southern District of New York charged 10 individuals in New York City, including seven medical professionals, for illegally distributing oxycodone. Read More
The FDA released new guidance Friday on how researchers can comply with both agency regulations and pending Common Rule revisions that protect human subjects in clinical trials. Read More
An FDA advisory panel voted 10-3 Friday that the benefits of AcelRX’s synthetic opioid candidate Dsuvia (sufentanil) outweigh its risks for treating moderate-to-severe acute pain. Read More
Purdue argued that the state cannot bring a public nuisance claim over lawful products, and that several of the public-nuisance allegations were outside of the 10-year statute of limitations. Read More
The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it will temporarily reduce or suspend more activities to save resources. Read More
An FDA advisory panel narrowly voted Thursday not to recommend approval of Trevena’s NDA for oliceridine, an opioid treatment for moderate-to-severe acute pain in adults. Read More
“We will not shy away from calling out instances where we believe brand firms may be leveraging tools intended to serve a useful purpose to instead thwart competition that can drive down prices for patients,” Gottlieb said. Read More
Congress is considering legislation that would narrow the eligibility requirements for hospitals. The Protecting Safety-Net 340B Hospitals Act, sponsored by Rep. Joe Barton (R-Texas), would raise the minimum Medicare reimbursement a hospital must receive to make the cut. Read More
But the New Jersey court disagreed, ruling that consolidating the suits in the Garden State — which has stronger protections for drugmakers who use FDA-approved labeling — was proper because that’s where the drugmaker was headquartered at the time. Read More