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

FDA Adds Homeopathic Enforcement Details, Subtracts Compliance Policy Guide

 
• By Malcolm Spicer

Revised draft guidance identifies types of homeopathics posing "higher risks to public health." FDA withdraws 1988 compliance policy guide that allows homeopathic to be available even though they are not subject to pre-market approval or other review process agency imposes on all other drugs.

Homeopathy_curtain_318107618_1200.jpg

The US homeopathic drug industry leaves too much to risk, says the Food and Drug Administration in cancelling a policy guide that linked compliance to industry standards rather than FDA approval and imposing a risk-based enforcement approach.

The agency on 24 October published a revised draft guidance for its oversight of the homeopathic industry, detailing its enforcement approach by identifying types of products that pose "higher...

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

‘We Must Have The Truth’ – Calls For UWWTD Review Intensify As Evidence Looks ‘Shaky’

 
• By David Ridley

The evidence underpinning the “polluter pays” principle of the revised Urban Wastewater Treatment Directive - which calls on Europe's pharmaceutical industry to cough up at least 80% of the cost of updating wastewater treatment facilities - is looking increasingly shaky, according to a new report.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

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.

More from Policy & Regulation

Self-Care Must Be Central To NHS Reform, Says UK Industry And Pharmacy Alliance

 
• By David Ridley

Ahead of a soon to be released 10-Year Health Plan for the English NHS, an alliance including PAGB calls for self-care to be “clearly recognised and supported through concrete policies that reflect its vital role in achieving the plan’s goals.”

Haleon Study: Boosting Health Literacy Could Save Major Economies Over $300bn Per Year

 
• By David Ridley

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.

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.