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

Cloud Over FDA Advisory Panel Meeting From ‘Over-Reporting’ In Birth Control OTC Switch Study

 
• By Malcolm Spicer

While HRA consultant says its study “meets or exceeds standards of most other studies assessing adherence, including an oral contraceptives,” FDA ONPD director says particpants’ over-reporting “is not something we see in a typical actual use study.”

• Source: Shutterstock

The US Food and Drug Administration is holding the line on requiring reliable data supporting an OTC switch application no matter how much and how often the sponsor describes the numerous public health benefits of expanding access to a daily oral contraceptive.

Agency officials, on 9 May during the first day of a two-day advisory panel meeting conducted online, also heard almost...

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

Like Claims Of Prenatal Acetaminophen Exposure Risks, Petition For Warning Is ‘Unreliable’ – CHPA

 
• By Malcolm Spicer

Scientific literature on potential link between prenatal acetaminophen exposure and neurological conditions “now includes FDA’s most recent epidemiological review” completed in May saying research results “insufficient to support a causal association.”

Norway Decides Against Tighter Restrictions For Ibuprofen

 
• By Tom Gallen

Norway's Medical Products Agency has rejected claims that misuse of OTC ibuprofen is linked to its availability for purchase in outlets other than pharmacies.

Latest OTC Eye Drop Production Problem In US Prompts Firm To Close Doors After Recalls

 
• By Malcolm Spicer

BRS Analytical Services in St. Louis recalled more than 75,000 cases of redness and lubricating eye drops and committed “to permanently cease production of all drugs.”

US FDA Plans Move Inspectorate Back To More Generalist Organization

 
• By Sarah Karlin-Smith and Derrick Gingery

The “Simple Reform” initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations.

More from Policy & Regulation

Norway Decides Against Tighter Restrictions For Ibuprofen

 
• By Tom Gallen

Norway's Medical Products Agency has rejected claims that misuse of OTC ibuprofen is linked to its availability for purchase in outlets other than pharmacies.

OTC Analgesic Pollutants In Scope Of EU Water Strategy Agreed By Council

 
• By David Ridley

EU legislation aimed at controlling at source emerging pollutants such commonly used OTC analgesics like ibuprofen and diclofenac and “forever chemicals” like perfluoroalkyl and polyfluoroalkyl substances (PFAS) edges closer to adoption.

Widen Access To Women-Specific Healthcare And Prevention, Say EU Citizens

 
• By David Ridley

A recent public consultation by the European Parliament’s Committee on Public Health (SANT) shows dissatisfaction with how women’s specific health needs are being met in the EU.