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Biden’s Budget Would Give $6.5Bn To FDA, Including $677M To Device Center

 
• By Elizabeth Orr

The funding plan from the US president, which is up 8% from fiscal 2021, prioritizes infrastructure, public health, and safety programs.

FIngertip flips a block to turn "2021 Budget" to "2022 Budget"

The US Food and Drug Administration would see an 8% financial bump under President Joe Biden’s proposed budget for fiscal 2022, which was released on 28 May. The agency justified its spending requests in a report to Congress.

The budget request would grant the FDA a total budget of $6.5bn, up $477m from fiscal 2021. The funds include $3.6bn in federal monies and $2.9bn in user fees. On...

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• By Amanda Maxwell

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

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

 
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Industry Execs Talk Tariff Turbulence During MD&M East

 
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More from Policy & Regulation

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

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry.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

 
• 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.