FDA’s Combo Product GMP Reg Speeds Ahead Unchanged

Agency decides to keep the proposed rule, issued in 2009, “largely identical” and denies requests to delay implementation a year.

FDA will implement its final rule on combination product Good Manufacturing Practices on time and mostly unchanged from the 2009 proposal, despite comments asking for an enactment delay and more guidance.

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 United States

More from North America