Surge Of FDA Activity Caps Quiet Year Of Promo Discipline

Law360, New York (January 7, 2014, 4:37 PM EST) -- The U.S. Food and Drug Administration on Friday released a letter chastising Dara Biosciences Inc. for allegedly overstating the benefits and downplaying the risks of cancer drug Soltamox, joining a recent flurry of activity in what was an otherwise sleepy 2013 for promotion-related enforcement.

In its Dec. 20 letter, the FDA criticized marketing materials it said improperly suggested that Soltamox's liquid formulation made it not only more convenient but also likely to improve patient adherence to important medication.

In addition, the FDA complained that certain risks were omitted from a brochure, and that readers instead were directed to review a package...

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

Attached Documents

Related Sections

Law Firms

Government Agencies

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!