Medicare administrators could negotiate lower prices with drug companies, potentially saving the federal government billions of dollars a year, under legislation House and Senate Democrats are introducing in Congress. Source:…
A Florida compounding pharmacy did not meet the criteria for exemption from FDA rules on good management practices, and it violated those rules, the FDA said in a warning letter.…
The Association of Clinical Research Organizations warned that the state of New Jersey’s plan to cap drugmaker payments to doctors may hold unintended consequences for drug development efforts. Source: Drug…
Vital Laboratories failed to report production deviations, perform proper product reviews or take needed corrective actions at its Gujarat, India, facility, the FDA said in a warning letter. Source: Drug…
Two new FDA draft guidances provide updates for developers on drug-drug interaction. Source: Drug Industry Daily
The FDA launched an educational campaign to inform healthcare providers about biosimilars and how they are approved and regulated. Source: Drug Industry Daily
The FDA continues to work to restore drug manufacturing crippled by hurricane Maria in Puerto Rico, with special response teams set up to tackle the job, but none of the…
An Alabama compounding pharmacy fell short of several standards for sterile drug processing, the FDA said in a Form 483 inspection report. Source: Drug Industry Daily
A Tennessee judge denied Endo Pharmaceuticals’ request to move a lawsuit against opioid makers from state to federal court. Source: Drug Industry Daily
An Illinois judge denied a request from Abbott Laboratories to throw out a suit accusing the drugmaker of failing to properly warn of safety risks associated with its drug Depakote.…