FDA Risk-Evaluation Guidance Unlikely To Help Generics

Law360 (June 12, 2018, 2:55 PM EDT) -- Last week, the U.S. Food and Drug Administration issued two draft guidances concerning risk evaluation mitigation strategies, or REMS, which are programs designed to track the use, and deter the potential misuse, of drug products that pose significant health risks. One guidance addressed the development of a single shared system for REMS.[1] The other addressed waivers from the SSS for REMS.[2] The FDA proffered these guidances as a means of enhancing cooperation and competition in response to complaints that brand drug manufacturers were using REMS requirements "to block timely generic entry."[3] Yet, however well-intended, their substance actually reveals the limits of...

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!


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!