1. HBW Insight
  2. >>Health
  3. >>Rx-to-OTC Switch

US FDA Checking Boxes On OTC Monograph Overhaul And In-Box For ACNU Switch Comments

‘Different’ OTC Space Coming From Monograph Program Reform, Proposed OTC Switch Changes

 
• By Malcolm Spicer

“Who would have said that, looking forward two or three years ago, we would be where we are now?” says FDA OTC office director Theresa Michele. Monograph reform and introducing “additional conditions for nonprescription use” options for NDA OTCs each is a “real gamechanger.”

• Source: Shutterstock

The Food and Drug Administration’s regulation of the US OTC drug space is being overhauled through changes to its monograph program made within deadlines set by Congress and a proposal to extend labeling for nonprescription drugs into the digital realm.

However, what access to nonprescription drugs will look like after monograph reform is completed and if “additional conditions for nonprescription use” (ACNU) options for OTC switch new drug applications become available, isn’t clear yet, says Theresa Michele, director

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 Rx-to-OTC Switch

Over The Counter: Taking Real-World Evidence Seriously, With IQVIA Consumer Health’s Volker Spitzer

 
• By David Ridley

In part 2 of HBW Insight's interview, IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer, explains how to approach real world evidence so that regulators recognize its validity, in supporting Rx-to-OTC switch applications, for example.

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
• By David Ridley

HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

More from Health

Kennedy Defends Spending Cuts During Contentious Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

Recordati Relying On OTC To Act As ‘Booster’ To Growth

 
• By Tom Gallen

In categories like cough & cold and gastrointestinal, OTC products have a pivotal role to play in helping Recordati hit its sales targets for the 2025-2027 period.

EU Parliament Calls For Review Of Wastewater Directive’s Impact On Pharma Sector

 
• By David Ridley

At a recent plenary session the European Parliament adopted a resolution calling on the European Commission to “conduct a new and comprehensive assessment” of the impact of the revised Urban Wastewater Treatment Directive on the pharmaceutical sector.