The former CEO of Utah-based device maker Dolor Technologies will be sentenced Nov. 8 on misdemeanor charges related to failure to seek FDA approval for a device to treat migraine…

CMS’s decision to allow coverage of positron emission tomography (PET) agents used to detect amyloid plaque deposits in the brain means patients suspected of having Alzheimer’s may now be covered…

The FDA’s new draft guidance provides recommendations on overall development programs for drugs to treat diabetic foot infections (DFI) as well as clinical trial designs. Source: Drug Industry Daily

The FDA’s final guidance alerts drugmakers and compounders to the potential health hazard of alcohol (ethyl or ethanol) or isopropyl alcohol that is contaminated with methanol. Source: Drug Industry Daily

As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…

Understanding FDA quality system requirements may be more confusing under the new Quality Management System Regulation (QMSR) due to be finalized in December, says one regulatory expert, but actual compliance…

PhRMA has asked the U.S. Supreme Court to grant petitions from the Department of Justice (DOJ) and Danco Laboratories and reverse the U.S. Court of Appeals for the Fifth Circuit…

Manufacturers of drugs and medical devices make several common errors when choosing the sample size for their sampling plan, but selecting too few samples routinely tops the list, according to…

Over the past week, the FDA issued final guidances on assessment of tissue containment systems, testing and labeling medical devices for safety in the magnetic resonance environment and draft guidance…

Sponsors of postmarket trials and certain phase 3 trials can now expect the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to process their trial applications within two weeks rather…