The Wait Is Over: US FDA Advisory Committees Returning To In-Person Meetings Come Fall

‘We’re coming back,’ Oncology Center of Excellence Director Richard Pazdur says. Office of New Drugs Director Peter Stein says transition from virtual to in person will be gradual because FDA is trying to be sensitive to adcomm members' need to schedule travel and demands on their time.

Welcome back
• Source: Shutterstock

US Food and Drug Administration advisory committees are heading back in person to the agency’s White Oak headquarters this fall after an absence of more than four years.

“First of all, we're coming back,” Oncology Center of Excellence Director Richard Pazdur said on 26 February. “I think that’s very important to get back in person.”

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

More from Regulation

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By 

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

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

 
• By 

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 

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 

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.

More from Policy & Regulation

Loper Bright ‘Might Not Be Cataclysmic’ With FDA’s ‘Good Reputation’ For Science – Attorney

 

Bridget Dooling, law school professor who reviewed draft regulations from FDA and other agencies as OMB attorney, says history of federal court decisions in litigation challenging FDA’s interpretation of statutes points to judges typically defer to agency decisions based in science.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By 

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.

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

 
• By 

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.”