News

Latest News | 17 May 2012

Committee Calls for Improved Pharmacovigilance, New Labeling Requirements in Europe

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The European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) is calling for new methods to monitor, label and withdraw dangerous medicines on an EU-wide basis.Under new [Read More...]

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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...]

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Latest News | 11 May 2012

Proposed Bill Would Mandate Passage of Device Identifier, Data Collection

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A new piece of legislation introduced in the House of Representatives by Rep. Lois Capps aims to expand postmarket tracking of medical devices and implement a mandate for the passage of a Unique [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 | 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

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 | 27 April 2012

European Commission Demands Bulgaria ‘Correctly Implement’ Regulatory Legislation

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What happens when an EU country fails to “correctly implement” a legislative directive? A harsh scolding from the European Commission (EC) and threats to haul the country before a the European Court [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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