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Latest News | 17 May 2012

New Provisions in Senate User Fee Bill as Vote Scheduled

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The Senate is scheduled to take up the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) on Thursday, 17 May, and numerous sources report new provisions have entered into the [Read More...]


Latest News | 14 May 2012

New Bill Would Subject Regulations to Quadrennial Legislative Review

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A new bill proposed in the US House of Representatives would require the Office of Information and Regulatory Affairs (OIRA) to compile a report every four years recommending certain regulatory [Read More...]


Latest News | 11 May 2012

After Numerous Delays, Legislation to Curb Drug Shortages to Advance in Congress

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In early 2011, several bills aiming to curb drug shortages were introduced in the US House of Representatives and the US Senate. Despite the bills’ bipartisan nature and widespread support, they’ve [Read More...]


Latest News | 10 May 2012

As User Fee Bill Sails Through House Committee Vote, a Focus on Industry Efforts

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The House Energy and Commerce Committee advanced the Food and Drug Administration (FDA) Reform Act of 2012, a package of proposals to both fund and reform the agency, by a unanimous vote involving 46 [Read More...]


Latest News | 10 May 2012

House Committee to Vote on User Fee Bill, Aiming for Passage in July

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The US House of Representatives’ Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) [Read More...]


Latest News | 10 May 2012

Bill Introduced to Speed Development and Review of Breakthrough Therapies

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A bipartisan bill introduced in the House of Representatives would work to speed up the development and review of some drugs intended to treat life-threatening diseases by creating a new “breakthrough [Read More...]


Latest News | 9 May 2012

House Subcommittee Passes User Fee Reauthorization Legislation

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The US House Energy and Commerce Subcommittee on Health completed its markup process for a package of user fee programs including the Prescription Drug User Fee Act (PDUFA), the Medical Device User [Read More...]


Latest News | 30 April 2012

Legislation Introduced to Require ‘Plain Writing’ for all Regulations

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The US Food and Drug Administration (FDA) could be statutorily required to use “plain writing” in all of its future regulations if a piece of proposed legislation has its way.The proposed bill, The [Read More...]


Latest News | 26 April 2012

User Fee Act Passes Senate Panel While Tensions Escalate in the House

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The Senate’s Health, Education, Labor and Pensions (HELP) Committee passed a collection of user fee acts in a piece of legislation known as the Food and Drug Administration Safety and Innovation Act [Read More...]


Latest News | 25 April 2012

Report: ‘Track and Trace’ Anti-Counterfeiting Provisions Likely Casualty of User Fee Markup

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A long-awaited and much-called-for plan to introduce a ‘track and trace’ plan to cut down on pharmaceutical counterfeiting may be cast by the wayside in the legislative markup process for new [Read More...]


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