News

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...]

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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...]

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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...]

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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...]

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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...]

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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...]

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Latest News | 8 May 2012

House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

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An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt [Read More...]

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Latest News | 8 May 2012

User Fee Bill Appears Ready to Pass House Subcommittee

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The US House of Representatives’ Energy and Commerce Subcommittee on Health meets 8 May to conduct its markup process for various user fee bills, including the Prescription Drug User Fee Act (PDUFA) [Read More...]

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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...]

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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...]

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