1. Pink Sheet
  2. >>Biosimilars & Generics
  3. >>Generics

Unfreezing US FDA: Generic Drug Officials Make Plea For Public Workshops

 
• By Michael McCaughan

The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.

OGD wants industry to amplify the perceived value of FDA public meetings. (Shutterstock)
Key Takeaways
  • During its first public event since the Trump Administration took office, OGD pleaded with industry to trumpet the value of the presentations if they were helpful.
  • Robert Lionberger said many FDA employees “had to go through some extra efforts” to stage the event, amid communications limits placed on the agency.
  • Lionberger also said that he hoped the presentations will help generic drug sponsors use the controlled correspondence process more efficiently and effectively.

The US Food and Drug Administration’s generic drugs regulatory team wants industry to speak up if it values agency-hosted public events.

The Office of Generic Drugs held its first public event of the second Trump Administration on 27 February, a webinar on best practices for controlled correspondence, which is a pathway...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Generics

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 
• By Derrick Gingery

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

More from User Fees

Missing BsUFA Revenue Trigger Could Open US FDA Staff To Criminal Penalty

 
• By Derrick Gingery

Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.