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

 
• By Sue Sutter

‘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
FDA is working to bring advisory committees back in person. • Source: Shutterstock

US Food and Drug Administration advisory committees are heading back in person to the agency’s White Oak, MD, 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.”

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More from Regulation

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.

More from Policy & Regulation

Industry Execs Talk Tariff Turbulence During MD&M East

 
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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
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Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.