FDA Floats Labeling Update For 100s Of Drugs

By Jeff Overley (May 6, 2014, 6:14 PM EDT) -- Aiming to jump-start a largely idle safety initiative, the U.S. Food and Drug Administration on Tuesday detailed plans for a government contractor to help pharmaceutical companies update warning labels for hundreds of older products.

The move stems from a 2006 regulation known as the physician labeling rule, which required prescription drugs approved after June 30, 2001, to adopt new formatting for disclosing risks, dosage and various scientific data.

That mandate has only resulted in label updates for 15 percent of the drugs on the market, and so the FDA is offering an incentive in hopes of winning voluntary compliance with the...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!