Tag: Regulatory approval
FDA Center for Clinical Trial Innovation: Improving Trial Processes and Patient Safety
In April 2024, the U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) introduced the Center for Clinical Trial Innovation (C3TI) to enhance communication and collaboration in clinical trials. C3TI aims...
Amneal Removes Teva Patents from Orange Book with FTC HelpAmneal FTC Success: Teva Patents...
In a recent court ruling, the United States District Court for the District of New Jersey has determined that Teva's inhaler patents were incorrectly listed in the FDA's Orange Book. This decision supports Amneal's...