1. HBW Insight
  2. >>Health
  3. >>Rx-to-OTC Switch

US FDA Looks To Assure Advisory Committees' Subject Expertise With More Temporary Members

Expect More Temporary Members Voting In US FDA Advisory Committees

 
• By Derrick Gingery

Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.

CDER Director Patrizia Cavazzoni, left, speaks with Cardinal Health's Assistant General Counsel Sonali Gunawardhana during an 18 May FDLI Annual Conference session.
CDER Director Patrizia Cavazzoni, left, speaks with Cardinal Health assistant general counsel Sonali Gunawardhana on 18 May during FDLI conference session. • Source: FDLI

Advisory committee reform for the US Food and Drug Administration’s Center for Drug Evaluation and Research includes product-specific adjustments to the group offering advice.

CDER Director Patrizia Cavazzoni expects more temporary members could be added to advisory committees going forward to ensure the groups’ “expertise applies precisely to the matters under consideration,” according to slides she

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 Rx-to-OTC Switch

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.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

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.

More from Health

Looming Tariffs Give Boost To Latest PCH Results While Cutting Costs In Response Takes Priority

 
• By Malcolm Spicer

Looming imposition of tariffs by Trump on imports from most every country had an influence on consumers during the January-March period, particularly on online shopping. Increasing product prices on the table, “but our efforts are going to start with cost savings,” says CFO Christine Sacco.

Global Alliance Urges UN General Assembly To Put Self-Care At Centre Of NCD Strategy

 
• By David Ridley

Including self-care in an upcoming UN General Assembly political declaration would be a “powerful signal that the global community is serious about non-communicable disease prevention and control,” argues the United for Self-Care Coalition, which includes the Global Self-Care Federation, International Self-Care Foundation and Imperial College London’s Self-Care Academic Research Unit.

Danes Get OTC Access To ED Treatment

 
• By Tom Gallen

Navamedic has launched Eroxon in Danish pharmacies giving men in the country OTC access to an ED treatment for the first time.