FDA

The United States Food and Drug Administration (FDA) recently issued two guidances as part of its Drug Competition Action Plan…

The United States Court of Federal Claims in Washington, D.C. recently denied the United States’ motion to dismiss Vanda…

A former employee of a medical device manufacturing company was recently sentenced to 12 months in prison and one year of…

The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) recently issued the first…

Recently, the United States Food and Drug Administration (FDA) finalized two guidance documents that outline how sponsors can use…

The Hastings Center recently released a report with a roadmap on how the United States Food and Drug Administration (FDA) can…

On December 27, 2023, the United States Food and Drug Administration (FDA) announced a new small entity compliance guide (SECG),…

The United States Food and Drug Administration (FDA) received more than 130 comments on its draft guidance on clinical diversity,…

Recently, the United States Food and Drug Administration (FDA) released the final rule for Direct-to-Consumer Prescription Drug…

The United States Food and Drug Administration (FDA) has extended the comment period for comments on the  revised draft guidance…