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

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.

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: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

More from Policy & Regulation

US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
• By Derrick Gingery

The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By David Ridley

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.