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Timers Start Ticking At US FDA In A Month For An Even Dozen OTC Monograph Meeting Requests

 
• By Malcolm Spicer

CDER Office of Nonprescription Drugs already accepts requests but won’t start responding until FY2023 begins on 1 October, also the start of FDA’s first year meeting with firms developing monograph changes and evaluating submitted proposals under deadlines included in program overhaul Congress authorized in 2020.

• Source: Shutterstock

The first 12 requests the US Food and Drug Administration received for meetings to discuss proposals for OTC monograph changes during fiscal year 2023 will start something all the subsequent requests won’t – a clock ticking on the agency’s response.

Although already accepting requests, the Center for Drug Evaluation and Research’s Office of Nonprescription Drugs won’t start

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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.