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Latest News | 22 May 2012

User Fee Bill Advances to Vote in Senate

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The Food and Drug Administration Safety and Innovation Act (FDASIA), the Senate’s iteration of a package of user fee legislation and other regulatory reforms, advanced in the Senate on 21 May, moving [Read More...]


Latest News | 15 May 2012

Senator Looks to Spur Development of Medicines Through ‘Prize Fund’

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A Senate hearing being held by Senator Bernie Sanders (I-VT) seeks to advance legislation that would create a prize fund for companies to create new medicines and vaccines, partially replacing 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

Senators Launch Investigation Into ‘Dubious Marketing Practices’ of Pain Pill Manufacturers

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Explosive allegations have emerged from two prominent Senators regarding marketing tactics used by a number of pharmaceutical companies, including Purdue Pharma, Endo Pharmaceuticals and Johnson & [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 | 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...]


Latest News | 1 May 2012

Report: FDA Meeting Review Goals Under PDUFA

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The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its [Read More...]


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