1. Pink Sheet
  2. >>Drug Safety

Codeine Concerns Cough Up FDA's OTC Monograph Problems

 
• By Malcolm Spicer

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
Start Free Trial

Already a subscriber?

More from Drug Safety

EMA Backs Insmed’s Brinsupri And Sanofi’s Wayrilz, Rejects Rezurock

 
• By Eliza Slawther

The European Medicines Agency’s human medicines committee, the CHMP, has recommended Insmed’s Brinsupri and Sanofi’s Wayrilz for pan-EU approval but turned down Sanofi’s Rezurock based on trial results that cast doubt on the drug’s efficacy.

Hong Kong To End Reliance On Overseas Drug Approvals

 
• By Anabel Costa-Ferreira

Hong Kong is pushing forward with its vision to build an “internationally renowned” regulatory authority of drugs and medical devices. Meanwhile, the Department of Health’s 1+ drug registration mechanism has received over 620 enquiries from over 160 pharmaceutical companies.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 
• By Bridget Silverman

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.

More Vaccines At Risk At Upcoming ACIP Meeting As New Panel Members Join

 
• By Sarah Karlin-Smith

The ACIP put hepatitis B and MMRV vaccines on its agenda, despite having no new reason to relitigate the products, worrying public health experts that more anti-vaccine moves are coming.

More from Pink Sheet

Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

 
• By Cathy Kelly

Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.

Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown

 
• By Sue Sutter

Sponsors should consider whether their TV commercials contain the same number of scene changes during the major statement as ads that received a violation letter.

Gene Therapy Sponsors Seek More US FDA ‘Platform’ Guidance, Offer Master File Idea

 
• By Michael McCaughan

One clear message from a US FDA listening session on leveraging knowledge across cell and gene therapy products is sponsors want more guidance on how the FDA’s new platform therapy pathway will function.