Impax Laboratories files a petition urging FDA to refuse to receive or approve any ANDA seeking approval to market a generic version of Rytary (carbid...
A group of government scientists warns president Trump that politics has no place in science, and any restrictions on scientific findings will lead to...
Reaction from FDA stakeholders on president Trumps plans to cut FDA regulations and speed product approvals argue that the effort is misguided.
The Justice Department says individuals from South Dakota and Canada have been charged in a scheme to defraud consumers by selling them medical device...
CVM approves four NADAs from Phibro Animal Health and Huvepharma for virginiamycin products against necrotic enteritis and coccidiosis in broiler and ...
Reps. Schrader and Bilirakis and nine other lawmakers introduce a bill to offer priority review vouchers to companies that develop new generic drugs w...
A WilmerHale review of False Claims Act cases in 2016 predicts that enforcement of the law will remain strong in the Trump administration.
FDA posts a revised MDSAP P0008 audit time determination document.