1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation

US OTC Monograph Overhaul Like Makeover To Resemble Other FDA Drug Application Programs

 
• By Malcolm Spicer

In draft guidance on format and content for OMORs, CDER framed recommendations by same model it’s used for guidances on other drug applications, common technical document for registration developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.

• Source: Shutterstock

A draft guidance moves the drug approval program used for availability of most of the nonprescription drugs marketed in the US further away from its gridlocked past and into the more efficient process used for approving many drugs in and outside the US.

In in the document published on 12 April, the Food and Drug Administration also moves information expected in OTC monograph...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight 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 Regulation

More from Policy & Regulation

FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

German Associations Call For EU Green Claims Directive Trilogue Suspension

 
• By David Ridley

Pharma Deutschland is one of 21 German associations calling for trilogue negotiations in relation to the EU Green Claims Directive to be suspended while a “comprehensive and independent written impact assessment” is undertaken.

Over The Counter: EU Omnibus And ESG, What You Need To Know, With CEN Group’s Jasper Crone

 
• By David Ridley

HBW Insight catches up with sustainability expert Jasper Crone to find out what consumer health companies need to know about the European Commission's Omnibus simplification package.