JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the Center for Devices and...more
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter from the US Food and Drug Administration (FDA) on the heels of a routine...more
The U.S. Securities and Exchange Commission’s (SEC) impending cyber disclosure rule, slated to commence on 15 December 2023, underscores an imperative shift towards a more transparent and accountable cybersecurity posture for...more