In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the ...

Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.

The warning letter relates to quality system issues identified during FDA inspections at three of the company’s facilities located in Mansfield, Massachusetts, Plainsboro, New Jersey ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

Oncology drugs tend to “percolate to the top” of shortage lists that prioritize drugs of concern, said expert.

In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...

Geewananda Gunawardana Ph.D. It is a relief to see that some actions are being taken to safeguard the nation’s medicinal ...

The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

In his first public comments since one of his executives was shot to death, UnitedHealth Group CEO Andrew Witty said the ...

The FDA recently updated the definition of "healthy" on food labels. The change reflects updates in nutrition science since ...

It takes nine months to complete the drug procurement process, thus there is no immediate solution to address various ...