Deepanshu Saini, Director of Program Management at IQVIA reflects on the interplay between safety and AI pharmacovigilance.

The FDA will require pharmaceutical companies to study whether their opioid products are effective treatments for chronic pain, reports The Washington Post. While some studies show opioids are ...

Opioid medications will now be required to have updated warning labels and safety information, according to a new mandate from the FDA. The requirements also extend to medication guides to provide ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. Originally established in 1938 and expanded in 1962, the FDA’s mandate has been to determine ...

In 2022, the Modernization of Cosmetics Regulations Act of 2022 (MoCRA) was signed into law, bringing about the largest expansion of the U.S. Food ...

The Food and Drug Administration (FDA) had rescinded emergency use authorizations (EUAs) for COVID-19 vaccines, Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday, saying ...

FDA Commissioner Scott Gottlieb dropped three new FDA guidance documents today, two draft guidances and a final guidance. One draft guidance is the long-awaited guidance on clinical (as well as ...