In an untitled letter issued in March, the regulator declared all in vitro data generated by CRO Raptim Research as ...

AbbVie told Stat that it had stopped airing the ad after the first half of the year and that it is complying with the FDA's investigation. So-called 'untitled letters' from the FDA for advertising ...

The recent warning and untitled letters have demonstrated that the FDA is reviewing websites and social media to find instances of non-compliant advertisements. Not following FDA regulations can ...

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

TLX101-CDx is an investigational positron emission tomography agent that targets the membrane transport proteins, LAT1 and LAT2.

has officially received the "No Questions" letter from the U.S. Food and Drug Administration (FDA) regarding its GRAS (Generally Recognized as Safe) status. The GRAS designation recognizes it as ...

Health and Human Services employees were told in March to remove 'nicknames' from email systems and signatures to comply with Trump order on gender.

Recent reorganizations and "reductions in force" at the FDA have damaged the very backbone of our public health system.

As a student of the University of the South Pacific studying human rights, one of my assignments is to write a letter to express my concerns in one of the human rights issues in Tonga. Drug use ...

Two-thirds to three-quarters of respondents who use tall man letters with look-alike drug name pairs felt this strategy was effective in reducing the risk of errors. Use on computer-generated ...

Community health centers across Illinois are uniting this spring behind one answer: legislation that will end dangerous restrictions on the popular, vital 340B federal prescription drug discount ...