FDA denies a Public Citizen petition seeking a narrower indication and labeling changes for Vanda's Hetlioz sleep disorder drug.
The California Superior Court orders Johnson & Johnson to pay $343.99 million in penalties for false and deceptive marketing of its pelvic mesh produc...
FDA warns R&B Medical Group about HCT/P deviations in its work as a contract testing laboratory.
Federal Register notice: FDA requests nominations for voting members to serve on CDRHֺֺs Patient Engagement Advisory Committee.
Federal Register notice: FDA posts a list of 16 information collections approved by OMB.
A survey of China-based active pharmaceutical ingredient makers and worldwide users indicates that suppliers may experience some disruptions during th...
Genus Lifesciences asks the DC federal court to rule that FDA unlawfully approved Lannetts Numbrino during a time when Genus had NCEE exclusivity for ...
FDA warns Wave Miami that it is distributing an unapproved and misbranded new drug containing an undeclared erectile dysfunction drug.