Codeine Concerns Cough Up FDA's OTC Monograph Problems

Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative process and to authorize a monograph user fee program.

syrup

FDA recently ordered label changes for Rx codeine drugs but could do nothing immediately and directly to affect marketing of OTC monograph drugs containing the ingredient. This disconnect provides more evidence that FDA should be empowered with flexibility to address these kinds of situations, as it can for prescription drugs, consumer health industry stakeholders say.

Additionally, the Pew Charitable Trusts suggests the case is clearly made for establishing user fees to support FDA’s work in...

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 Drug Safety

More from Pink Sheet

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By 

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.