The FDA updated its nearly 15-year-old policy on performing environmental assessments and reviewing potential exclusions under the Office of Pharmaceutical Quality. Source: Drug Industry Daily
The FDA approved the first U.S. biosimilar for the treatment of cancer, Amgen’s Mvasi, a biosimilar of the blockbuster Avastin. Source: Drug Industry Daily
A New York maker of homeopathic medicines that include toxic ingredients ran afoul of the FDA because it made drug-like claims for its products but did not manufacture them to…
Drugs to treat heart disease are taking a shrinking slice of the FDA approval pie, a Tufts University study says. Source: Drug Industry Daily
Congress is considering giving the FDA authority to regulate over-the-counter products through user fees and administrative action, similar to how it regulates prescription drugs. Source: Drug Industry Daily
Application fees for prescription drug approvals will increase by nearly 20 percent in fiscal 2018, starting Oct. 1, the FDA said in a Federal Register filing. Source: Drug Industry Daily
A federal court invalidated five Mallinckrodt Pharmaceuticals patents on its Inomax respiratory treatment system in response to the company’s own lawsuit against Praxair. Source: Drug Industry Daily
The Department of Homeland Security issued an advisory over major software vulnerabilities in two versions of Philips Healthcare’s web application DoseWise Portal (DWP) that can give hackers access to protected…
The FDA said it could find no evidence that tubes made by Becton Dickinson for Magellan Diagnostics’ blood lead-level testing devices contributed to inaccurate readings from the devices, which Magellan…
Australia’s Therapeutic Good Administration issued an update on its product review investigation of heater-cooler devices after more patients were found to be infected with Mycobacterium chimaera infections following heart surgery.…