Generic-Drug Makers Urge Changes To User-Fee Law

By Jeff Overley (June 15, 2015, 6:39 PM EDT) -- The generic-drug lobby on Monday outlined its hopes for improving and renegotiating the 2012 user-fee law that exchanged industry cash for better approvals and inspections at the U.S. Food and Drug Administration, arguing for quicker implementation, relaxed fees and other tweaks.

Corporate officials and regulators both spoke throughout the five-hour hearing hosted by the FDA, which analyzed the impact of the Generic Drug User Fee Amendments of 2012 and set the stage for early talks this fall on required reauthorization of the statute in 2017. Both sides acknowledged problems and successes, with business interests emphasizing the former and FDA staffers concentrating...

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!