FDA launches its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regulatory engagement and more predictable oversight for new facilities.
A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device labels.
FDA launches its new PreCheck pilot program aimed at strengthening domestic pharmaceutical manufacturing by providing earlier regulatory engagement and more predictable oversight for new facilities.
A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device labels.
Florida’s FDA-authorized drug importation program stalls and has yet to deliver any imported medicines more than two years after receiving final agency approval.
FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating Type I allergic reactions.
