Tag: fda

The Long (Un)Winding Road: FDA Maps Out How the End of the Public Health Emergency Will Impact its COVID-19 Policies ...

Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug ...

For sponsors utilizing a data monitoring committee in their trial designs to monitor for emerging safety signals, lack of effect, ...

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 (“PIE Act”) was passed as part of Congress’s December 23, ...

The U.S. Patent and Trademark Office (“USPTO”) published a Notice in the Federal Register announcing a new pilot program entitled, ...

When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” ...

After a recent reminder from the U.S. Patent and Trademark Office (USPTO) regarding the duties of disclosure and reasonable inquiry ...

The new Director of the U.S. Patent and Trademark Office (USPTO), Katherine Vidal, published a stern reminder regarding the duties ...

On September 28, 2022, the U.S. Food and Drug Administration (“FDA” or “the Agency”) issued its long-awaited final guidance, “Clinical ...

FDA Announces Total Product Life Cycle Advisory Program (TAP) Pilot - Life Sciences Perspectives FDA Announces Total Product Life Cycle ...