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

Illumina inks deal with J&J, AstraZeneca, Sanofi

The goal is to develop companion diagnostics to match patients with cancer treatments.

Abbott deal highlights inversion inaction

Political furor over the recent spate of tax inversions is having little influence on how the government chooses its partners.

Allergan reported to seek out Salix deal

The Wall Street Journal says the deal would add "another layer of intrigue" to the Allergan-Valeant hostilities.