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

Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...

In addition to the Notice, the FDA released a 20-page “Untitled Letter” outlining objectionable circumstances that the Agency found at Raptim.

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.

A Houston-based compounding pharmacy that was recently roped into Eli Lilly’s fight against knockoff GLP-1s has landed in the ...

In January, the FDA released a warning letter about a new canine allergy drug called Zenrelia. The letter updated safety ...