Label Expansion: Could Clinical Experience Data Find Supplement Work-Around?

Friends of Cancer Research seeks way of allowing high-quality efficacy data into label when supplemental NDA is not feasible.

Blister Packs

The US FDA may have to create a new system to incorporate post-marketing information into labeling for older off-patent drugs long used off-label.

Jeff Allen, president and CEO of the Friends of Cancer Research, said in an interview that FOCR does not believe that everything contained in clinical guidelines or compendia, which are...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

More from Policy & Regulation