How to Withdraw a Drug: FDA’s Final Decision on Avastin

The “streamlined withdrawal” process for Avastin in metastatic breast cancer gave Genentech an extra 11 months to prepare for the transition to off-label status. It also gave FDA time to make preparations of its own.

It took almost exactly 11 months for FDA to finalize its decision to pull Roche /Genentech Inc. 's Avastin (bevacizumab) metastatic breast cancer indication.

Like everything else in the first-of-its-kind “streamlined withdrawal” process, that sets a precedent.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Post-Marketing Regulation & Studies

More from Product Reviews