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

US FDA Wants Six-Month Premarket Notice Before Manufacturers’ First Monograph OTC Launches

 
• By Malcolm Spicer

Agency wants time to ensure compliance with GMP regulations before drug makers, such as an Indian firm which provided artificial tear eye drops currently on recall in the US after the products were linked to serious adverse events, distribute OTC monograph drugs for the first time.

• Source: Shutterstock

Nonprescription drugs are available in the US “non-application,” or without premarket approval, by complying with the Food and Drug Administration’s OTC monograph for formulations, indications and delivery formats.

The agency wants authority to have time to ensure compliance with its good manufacturing practices regulations products are distributed by monograph drug makers, such as an Indian firm which provided artificial tear eye drops

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

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.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

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.

More from Policy & Regulation