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By Daniel Kracov, Mahnu Davar, Bryant M. Godfrey, Raqiyyah Pippins, Abeba Habtemariam, Elizabeth Trentacost
The following chart provides an update (as of January 11, 2019) on the status of Food and Drug Administration (FDA) activities and programs ...
By Jacqueline Mulryne
Earlier this week, the Commission published a new Regulation amending Regulation 726/2004 that governs the centralised procedure and that sets out the rules ...
By Stephen C. Wallace
It has been one year since President Trump signed into law the most significant revision to the Internal Revenue Code since 1986, with the enactment of the Tax Cuts and Jobs Act (TCJA).
By David Sausen, Carey W. Smith, C. Sarah Soloveichik, Ashley Slisz
The Tax Cuts and Jobs Act (Tax Act), enacted in December 2017, offers new tax incentives for taxpayers that invest through special investment vehicles known as "qualified opportunity funds" (QOFs)
By Edward McTiernan, Ethan Shenkman, Allison B. Rumsey
Since its passage in 1972, courts have agreed that the Clean Water Act (CWA) does not cover discharges into isolated groundwater.
By Hannah Kerr-Peterson, Jacqueline Mulryne
As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...
By Michael A. Rogoff, Manvin Mayell, Debra Schreck
In remarks at the American Conference Institute's FCPA conference on November 29, 2018, Deputy Attorney General Rod Rosenstein announced changes to the DOJ's policy concerning individual accountability for corporate wrongdoing.
By Mark Colley, Christian D. Sheehan
The Granston Memo made an unexpected appearance in the Supreme Court on Friday.
By Tirzah S. Lollar, Alexandra Barbee-Garrett
The Ninth Circuit last week delivered a mixed bag of an opinion for defendants when it denied rehearing and rehearing en banc of its August decision affirming denial of summary judgment in U.S. ex rel. Rose v. Stephens Institute.
By Michael Gerrard, Edward McTiernan
In 2018, New York State enacted a Drug Take Back Act in response to environmental and public health concerns about improper disposal of unused drugs.
By Christian D. Sheehan
After years of procedural wrangling, defendants moved to dismiss.
By Kathleen C. Cooperstein
In practice, courts are somewhat scattershot in terms of their typical protocols. Some judges will order partial unsealing as a matter of course.
By Kathleen C. Cooperstein, Tirzah S. Lollar
The second key takeaway is that DOJ was only able to post these mediocre numbers by the skin of its teeth.
By Arturo Caraballo, Rashmi Seth, Skanthan Vivekananda
In the fall of 2017, the Board of Governors of the Federal Reserve System, the Federal Deposit Insurance Corporation (FDIC) and the Office of the Comptroller of the Currency ...
By Christian D. Sheehan
As predicted, the Supreme Court today denied certiorari in Gilead Sciences, Inc. v. U.S. ex rel. Campie—an outcome that was virtually guaranteed last month when the government's CVSG brief promised to voluntarily dismiss ...
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