White House Continues To Push For Higher User Fees From Industry

The White House expressed general support for the US House-passed user fee reauthorization bill while also demanding user fees be increased, creating some confusion in industry.

While the current bill reauthorizing US FDA user fees seems to be a done deal in Congress, the Trump White House continues to insist medical products industries pick up the entire tab for reviewing drugs, biosimilars and devices.

On July 12, the House passed the FDA Reauthorization Act or FDARA, which includes user fee authorizations for drugs, biosimilars and medical devices as well as several riders addressing medical...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech 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 Legislation

More from Policy & Regulation

Zika Virus Test Among 4 New FDA Device Classifications

 
• By 

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

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

Industry Execs Talk Tariff Turbulence During MD&M East

 

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.