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Bradley Arant Boult Cummings LLP | USA | 16 Apr 2019

Proposed Updates to Alabama Business Tax Laws: Summary of the Financial Institution Excise Tax Reform Act of 2019 and Alabama Innovation Act

Two landmark bills were introduced in the Alabama Legislature on April 11, potentially affecting numerous businesses in the state. Committees of the…

Covington & Burling LLP | USA | 11 Mar 2019

Net Neutrality Update: House Hearing and Proposed Legislation

Since the Federal Communications Commission (“FCC”) repealed the 2015 net neutrality rules last year, federal and state lawmakers have debated how to…

Mintz | USA | 7 Mar 2019

Device Modernization Series: In Vitro Clinical Tests

In our first two Device Modernization series posts, we discussed FDA’s 510(k) modernization efforts and the proposed De Novo regulation. FDA has also…

Seyfarth Shaw LLP | USA | 6 Mar 2019

Biosimilar IPRs: Timing is Everything . . . But When is The Right Time?

Timing the filing of an inter partes review for companies in the early stage of developing a biosimilar product should be carefully considered based…

Loeb & Loeb LLP | USA | 28 Feb 2019

FDA Regulatory and Compliance Monthly Recap — February 2019

The guidance outlines the principles for premarket review of combination products and discusses how to determine which type of premarket submission…

Cooley LLP | USA | 14 Feb 2019

New bill to exempt low-revenue companies from SOX 404(b)—have we reached an inflection point?

A bipartisan group of Senators has introduced a new bill, the Fostering Innovation Act of 2019 (S. 452), that would amend SOX to provide a temporary…

Jones Day | USA | 14 Feb 2019

IPR Appeal Dismissed After Biosimilar Development Discontinued

Article III of the Constitution imposes a “case or controversy” limitation on the jurisdiction of federal courts: an actual case or controversy must…

Barnes & Thornburg LLP | USA | 7 Feb 2019

FDA Issues Final Guidance on Least Burdensome Provisions for Medical Devices

Congress has directed the FDA to conduct premarket evaluations of medical devices in the least burdensome manner possible, consistent with…

Brownstein Hyatt Farber Schreck LLP | USA | 28 Nov 2018

Committee on Ways and Means Releases Tax and Oversight Bill

On Nov. 26, 2018, the Committee on Ways and Means released the tax and oversight package. The bill includes: Technical Corrections - Related to the…

Brownstein Hyatt Farber Schreck LLP | USA | 18 Sep 2018

Tax & Representation, September 18, 2018

On Sept.13, the tax writing committee marked up Tax Reform 2.0. While no one expected the same amount of enthusiasm for Tax Reform 2.0 as the original…
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