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

OTC DFL ‘Remains Static, Non-Customizable Tool’ As US FDA Lifts Curtain On Potential Changes

 
• By Malcolm Spicer

Webinar on DFL requirements was a good launch toward potential changes, says CDER Office of Nonprescription Drugs Director Theresa Michele, "This is a great opportunity for us. I think we are on the cusp of a lot of neat things in the OTC marketplace."

In an FDA webinar slide, California State University, Sacramento, marketing researcher Jesse Catlin captured the consensus about OTC DFLs required by the agency. • Source: Jesse Catlin/FDA webinar

Drug Facts labels required for OTC drugs available in the US have been a success but leave a lot of room for improvement, according to a consensus of Food and Drug Administration officials and drug labeling experts.

“Having been in the marketplace for 20 years, the remarkable safety profile of OTC drugs using the DFL format I think it speaks for itself,” said Jesse Catlin, a California...

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

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.

US FDA Expands Surprise Foreign Inspections

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

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.

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.

More from Policy & Regulation

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.

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.

Global Alliance Urges UN General Assembly To Put Self-Care At Centre Of NCD Strategy

 
• By David Ridley

Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.