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

What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections

 
• By Bowman Cox

Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.

covid-19 covid19 coronavirus puzzle and question mark ask future next step, next day, solution background - 3d rendering

Experts say the drug industry should use the opportunity provided in recent US Food and Drug Administration guidance to volunteer information the agency can use in lieu of site inspections it cannot conduct due to the coronavirus pandemic.

The idea is that new types of information could help persuade the FDA to approve applications without inspecting manufacturing sites or to re-classify

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