Pattern seen in OPDP warnings

Share this article:

Drugmakers looking for wiggle room should keep such hopes far from any drugs with a boxed warning. The blog Eye on 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:
You must be a registered member of MMM to post a comment.
close

Next Article in Agency Gallery

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Agency Gallery

Agency Business briefs: June 2014

Agency Business briefs: June 2014

News on Publicis, Palio+Ignite, PulseCX, McCann HumanCare and GolinHarris

It's time to replace the FDA, says Newt Gingrich

It's time to replace the FDA, says Newt ...

Former Speaker of the House and presidential candidate Newt Gingrich has declared that it's time to replace FDA

Agency Business briefs: May 2014

Agency Business briefs: May 2014

Newson ID Media, Frontline Medical Communications and ContextMedia