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

Plate Already Full Responding To Pandemic, US FDA Took On OTC Monograph Reform, ACNU Proposal

 
• By Malcolm Spicer

“The nonprescription drug space has been a bit challenging over the past two to three years as a result of the pandemic,” says CDER director Patrizia Cavazzoni.

• Source: Shutterstock

The Food and Drug Administration can’t be accused of ignoring the OTC drug industry during the COVID-19 public health emergency. During the pandemic, it’s launched a monograph program overhaul and proposed a rule to broaden Rx-to-OTC switch opportunities.

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

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.

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 
• By Jessica Merrill

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

More from Policy & Regulation

Criticism Of US Progress On Sunscreen Ingredient Innovation Demands OMUFA Hearing Spotlight

 
• By Malcolm Spicer

Discussion of introducing additional OTC sunscreen ingredients escaped a total eclipse criticism of Trump’s health agency layoffs caused. Comments and questions by Republican members joined by several Democrats and focused testimony and answers by witnesses representing the industry and public health groups spotlighted sunscreen.

Pharma Exhales, Dodges Financial Blow With Tariff Exemption

 
• By Jessica Merrill

Industry lobbing for pharmaceuticals to be exempt from President Trump’s sweeping US tariffs appears to have paid off.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.