The U.S. Food and Drug Administration (FDA) announced new Q&A draft guidance on the “Transfer of a Premarket Notification (510(k)) Clearance,” ...

Molecularly imprinted polymers were commonly used for drug delivery. However, single-template molecularly imprinted polymers often fail to achieve both drug delivery and precise targeting. To address ...

You’ll find everything you need to decode a sunscreen label below. FDA meaning: The sunscreen can protect you from the sun’s harmful ultraviolet A (UVA) and ultraviolet B (UVB) rays. Another confusing ...

The FDA is requiring Pfizer/BioNTech and Moderna to expand warning labels on COVID-19 vaccines. The agency cited estimates of myocarditis and pericarditis and study data showing the persistence of ...

WASHINGTON D.C. – The U.S. Food and Drug Administration (FDA) now requires expanded warning labels for Pfizer/BioNTech and Moderna’s COVID-19 vaccines to include more detailed information ...

The Food and Drug Administration is also fielding more submissions in recent years, with the 223 AI devices authorized in 2023 being the most in the agency’s history. As of the FDA’s latest data ...

The system is tailored to integrate with current surgical procedures. Credit: Max Acronym / Shutterstock. The US Food and Drug Administration (FDA) has granted breakthrough device designation for ...

The charges include conspiracy to distribute methamphetamine, fentanyl, cocaine, heroin, and marijuana, along with related firearms and drug trafficking offenses. SEE ALSO: Damien McDaniel faces ...

Credit: Marlon Trottmann / Shutterstock. The US Food and Drug Administration (FDA) has granted approval to Roche’s VENTANA MET (SP44) RxDx Assay to help determine the expression of ...

Elucent Medical announced today that it received FDA breakthrough device designation for its EnVisio X1 In-Body Spatial Intelligence system. Minneapolis-based Elucent designed EnVisio X1 to set ...