FDA Proposes Stricter Rules On Drug Label Changes

By Christine Caulfield (January 16, 2008, 12:00 AM EST) -- The U.S. Food and Drug Administration has published proposed regulation changes to drug and medical device labeling that would restrict the rights of pharmaceutical manufacturers to change product labels without agency approval.

The proposed revision comes as the U.S. Supreme Court considers whether to hear argument by drugmaker Wyeth Pharmaceuticals Inc. that federal laws governing labeling take precedence over state product liability legislation.

The new rules, if adopted, would limit the ability of drug companies to unilaterally alter labels under a "changes being effected" product supplement before FDA review.

The law as it stands allows manufacturers considerable leeway to revise labels,...

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!