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White and Williams LLP

Spending Bill Expected to Eliminate Certain Taxes

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The congressional spending bill for 2020 will be released today. Reports indicate that the bill will permanently repeal three separate taxes originally implemented by the Affordable Care Act (ACA). All three of the taxes are...more

Smart & Biggar

Rx IP Update - March 2019

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

Hogan Lovells

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization

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Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward advancing its previously reported goal to...more

Hogan Lovells

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

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The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019.  Unfortunately, FDA is one of the agencies with at least some...more

BakerHostetler

Capitol Hill Healthcare Update

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TRUMP TO RELEASE FISCAL 2019 BUDGET THIS MORNING - The White House this morning is releasing President Trump’s fiscal 2019 budget blueprint, which will include funding requests for HHS, FDA, CMS and dozens of other...more

Mintz - Health Care Viewpoints

August 2017 Is Here – Will FDARA Get Done Soon?

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It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act...more

Baker Donelson

Washington, D.C. Update – June 2017

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Having returned from its Memorial Day recess, Congress now enters one of the longest continuous work periods of the year and – with the exception of the week of the Fourth of July – will likely be in session until the end of...more

Mintz - Health Care Viewpoints

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

Mintz - Health Care Viewpoints on

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

Foley & Lardner LLP

Trump's Proposed 2018 Budget Will Double FDA User Fees

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During his speech last month to a joint session of Congress, President Trump called out the U.S. Food and Drug Administration for its “slow and burdensome approval process.” Those comments came on the heels of Trump’s...more

McGuireWoods LLP

Washington Healthcare Update

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On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

King & Spalding

Washington Insight - Special Edition: Congress Steps Away From Fiscal Cliff

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For months in Washington, and beyond, attention has been focused on the "fiscal cliff" -- the combination of the expiration of the Bush tax cuts and the looming budget cuts referred to as "sequestration." Negotiations led by...more

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