The FDA’s list of regulations it plans to propose or finalize in the next 12 months, released Tuesday, includes more than 30 proposed and final rules related to drug, device…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Source: Drug Industry Daily
An artificial intelligence platform can discern epileptic seizure patterns on electroencephalogram as well as an expert epileptologist, with nearly 100 percent accuracy, a finding that could extend expert diagnoses to…
Dose optimization for pediatric cancer drug trials shouldn’t rely on exhaustive analyses of toxicity, the FDA says, and members of an advisory subcommittee on pediatric oncology agree that children can’t…
Coherus BioSciences has resolved a key piece of its dispute with AbbVie over plans to market Yusimry (adalimumab-aqvh), a biosimilar for AbbVie’s blockbuster immunotherapy Humira, enabling it to begin selling…
Failure to establish corrective and preventive action (CAPA) plans tops the list of devicemakers’ FDA inspection observations year after year, but the situation is more nuanced than you might expect,…
Two clinical trials of Mersana Therapeutics’ ovarian cancer drug UpRi (upifitamab rilsodotin) are on a partial clinical hold from the FDA because of five deaths linked to serious bleeding. Source:…
Over the past week, the FDA issued final guidance on content of premarket submissions for device software functions. Source: Drug Industry Daily
The industry association representing pharmacy benefit managers (PBM) has fired back at the introduction of a Senate bill that would curtail their revenue based on the price of the drugs…
Neuronetics has received FDA 510(k) clearance for its NeuroStar motor threshold (MT) cap to treat obsessive-compulsive disorder (OCD). Source: Drug Industry Daily