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Latest News | 9 May 2013

Veterinary User Fee Bills Move Forward in Congress as Approval Appears Likely

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Congressional legislators have nearly cleared a new piece of legislation that would reauthorize the US Food and Drug Administration (FDA) to collect and spend user fees to facilitate and expedite the Read More...


Latest News | 8 April 2013

Legislators Reveal Text of Veterinary User Fee Bills, Free from Potential Markups

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US legislators on the House of Representatives' Energy and Commerce Committee have finally released the draft versions of two bills that would serve to reauthorize industry-paid user fees for both Read More...


Latest News | 4 April 2013

New FDA Guidance Clarifies Process for Submission of Device User Fees

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A new guidance document published by the US Food and Drug Administration (FDA) establishes and otherwise clarifies the process by which biopharmaceutical and medical device companies need to pay user Read More...


Latest News | 17 September 2012

More than $110 Million in FDA User Fees to be Seized Under Sequestration

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The US Food and Drug Administration (FDA) stands to lose more than $300 million in funding and industry-paid user fees under a budget sequestration process scheduled to come into effect in January Read More...


Latest News | 23 August 2012

Hamburg: Device Approvals Process Set to Become Less Burdensome

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The head of the US Food and Drug Administration (FDA) thinks the approval process for medical devices is about to become considerably smoother thanks to the passage of the Medical Device User Fee Read More...


Latest News | 10 July 2012

UPDATED: Obama Signs FDA User Fee Bill Into Law

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US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012—12 days after the Senate approved the bill and 17 days after the House of Read More...


Latest News | 27 June 2012

Senate Passes FDA User Fee Legislation, Bill Now Moves to White House

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In an expected development, the US Senate on Tuesday (26 June) voted overwhelmingly to approve the Food and Drug Administration Safety and Innovation Act (FDASIA), advancing the bill to the White Read More...


Latest News | 26 June 2012

FDASIA Legislation Moves to Vote in Senate

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The Food and Drug Administration Safety and Innovation Act (FDASIA), a massive piece of legislation aimed at renewing industry funding provisions for the US Food and Drug Administration (FDA) and Read More...


Latest News | 21 June 2012

FDA User Fee Bill Easily Passes the House, On Pace for July Approval

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The Food and Drug Administration Safety and Innovation Act (FDASIA) is set to be voted on in the Senate next week after receiving overwhelming approval from legislators in the US House of Read More...


Latest News | 20 June 2012

House to Vote Wednesday on FDA User Fee Legislation

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The US House of Representatives is preparing to vote on a piece of user fee legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA) as early as Wednesday, 20 June, Read More...


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RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

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