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The FDA released draft guidance Monday on how sponsors of treatments of rare diseases can get more from their pre-investigational new drug meetings with the agency. Read More
The FDA might be willing to extrapolate clinical data for targeted therapies even if sponsors can’t recruit patients with a specific genetic variant of the disease being treated, the agency says in the first of two guidance documents issued Monday. Read More
The Centers for Medicare and Medicaid posted a proposed rule Monday that would require drugmakers to include the list price of their products on TV ads, aiming to implement one element of the Trump administration’s blueprint for lowering drug prices. Read More
The complaint alleges that Westminster knew there were problems with the drugs for months but didn’t recall them until after the FDA forced its hand. Read More
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