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Latest News | 23 May 2013

New Legislation Seeks Creation of Provisional Approval Pathway for New Drugs

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Three US legislators have moved to introduce legislation they say would accelerate US Food and Drug Administration (FDA) approvals while giving patients the option to obtain therapies outside of Read More...


Latest News | 23 May 2013

Senate Advances Compounding, Track and Trace Legislation with an Eye on July Passage

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The US Senate's Health, Education, Labor and Pensions (HELP) Committee has advanced two long-sought-after proposals that would overhaul the framework by which the US Food and Drug Administration (FDA) Read More...


Latest News | 20 May 2013

Reform Bill Takes Aim at 'Gray Market' Causes for Drug Shortages

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A prominent congressional Democrat this week announced the reintroduction of a bill that looks to ban the practice of so-called "gray market" drug sales, the practice of which has been partially Read More...


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 | 29 April 2013

New FDA Deputy Commissioner Announced

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The Secretary of  the US Department of Health and Human Services (DHHS), Kathleen Sebelius, has placed her Chief of Staff, Sally Howard, in FDA’s Office of the Commissioner as the new Deputy Read More...


Latest News | 17 April 2013

Draft IVD Proposal Would Strengthen Clinical Testing Requirements

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A new draft legislative report issued by a member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), Peter Liese, would make significant changes to the Read More...


Latest News | 16 April 2013

New Law Rolls Back Provisions Requiring Top Regulators to Make Public Their Finances

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Top US regulatory officials may well be breathing a sigh of relief this week as at first legislators, and then finally the president, moved to pass a measure into law that would roll back new 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 | 27 March 2013

President Signs into Law Budget Bill that Restores FDA's Authority to Spend User Fees

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A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the Read More...


Latest News | 7 March 2013

Medical Countermeasure Bill Clears Congress, Set for President's Approval

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A disaster and emergency preparedness bill that would task the US Food and Drug Administration (FDA) with setting up new regulatory incentives and accommodations for medical countermeasures has passed 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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