The Realized Benefits of User Fees

OFW Law Celebrates 35 Years of Successes in Drug/Healthcare Privacy Practices (Part III) In celebrating 35 years of practice, OFW Law’s Drugs, Biologics, and Controlled Substances and Healthcare Privacy practice groups are taking a look back to sha… Read More
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Following the Money: House And Senate Appropriations Release Draft Bills & Reports Funding FDA For FY 2015

The House and Senate Appropriations Committees with oversight of FDA have been very busy. Both voted out draft bills for FY 2015 that include appropriations for FDA and released draft reports. Roger Szemraj and the rest of our government relations pr… Read More
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House Agriculture Appropriations Subcommittee Reports FY 2015 Bill Without Any Amendments

The House Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Subcommittee today voted by voice vote to approve its draft FY 2015 bill and report it to the full House Appropriations Committee. The full Com… Read More
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Generic Drug User Fee Act Information Technology Plan

Today, FDA published a notice in the Federal Register announcing the availability of the Generic Drug User Fee Act (GDUFA) Information Technology (IT) Plan. The plan explains FDA’s approach for enhancing business processes, data quality and consist… Read More
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Categories: FDA

Bienvenue Aux Etats-Unis!

With so many of our respected friends and colleagues furloughed, federal agency budgets decimated, or wholly dependent on user fees to operate, and so much important business on hold due to the intransigent federal budget showdown, it’s not surpris… Read More
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2012 in the Rear View Mirror

Now that that the Christmas stockings, Hanukkah menorahs and Kwanzaa harvest symbols have been put away until year end, and resolutions for 2013 have been written (and hopefully not broken yet!), it’s time for a little reflection. What follows is m… Read More
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Safety v. Innovation – How the European Commission’s Proposed Regulation Hopes to Strike the Right Balance

By Kathryn E. Balmford Back in January, Jeff Shuren, M.D., the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA), made headlines when comparing the European Union’s (EU) regulation of medical… Read More
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