Researcher finds black-box drugs have high Warning Letter risk

Share this article:

Drugmakers looking for wiggle room should keep such hopes far from any drugs with a boxed warning. Eye on the FDA took a look at the Warning Letter trends from 2004 through 2012 and found that the government agency is more likely to hit a drugmaker over materials associated with black-box drugs with a Warning Letter rather than with the less-intense untitled letter.

The blogger found that Warning Letters accounted for 34% of the FDA's Warning and Untitled letters, and that 45% of those Warning Letters were for drugs with black-box warnings, while box-free drugs accounted for 32% of the Warning Letters.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

FDA reviews new painkiller

The candidate would be the first to put oxycodone and morphine in one capsule.

AbbVie's files all-oral HCV drug with FDA

AbbVie's all-oral HCV treatment filed off six Phase-III trials spanning 25 countries and 2,300 patients

Rumor: Pfizer offered to buy AstraZeneca

The rumored $101 billion bid would give Pfizer a foothold in imuno-oncology and diabetes.