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By David Freeman, Jr., Richard Alexander, Christopher Allen, Robert Azarow, Michael Mancusi, Brian McCormally, Erik Walsh, Amber A. Hay, Kevin Toomey
n December 3, 2018, the federal bank regulatory agencies, the National Credit Union Administration and the Financial Crimes Enforcement Network (FinCEN) ...
By John Schmidt
On 5 December 2018, the High Court rejected Concordia's application to obtain full access to the information underpinning the Competition and Markets Authority's (CMA) ...
By Adela Williams
The case arose from the reimbursement by the Italian authorities of medicinal products used for an indication for which they are not authorised
By Lincoln Tsang
There are around 7,000 rare or ‘orphan' diseases for which there currently exists no authorised or satisfactory method of treatment.
By Daniel Kracov, Peter Levitas, Amanda Croushore, Matthew Tabas
On December 4, 2018, the US Federal Trade Commission released a comment responding to the Food and Drug Administration's October 2, 2018 revised draft guidance titled Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) ...
By Daphne Morduchowitz, Vincent Sama, Catherine B. Schumacher, Paul Andrews
On December 3, 2018, eight justices of the Supreme Court heard argument on whether a misstatement claim that does not meet the elements set forth in Janus Capital Group, Inc. v. First Derivative Traders, ...
By John Bellinger, III, John Barker, Charles Blanchard, Ronald Lee, Ronald K. Henry, Soo-Mi Rhee, Claire Reade, Nancy L. Perkins, Nicholas Townsend, Emma Dinan
The US Department of Commerce Bureau of Industry and Security (BIS) recently issued an advance notice of proposed rulemaking (ANPRM) ...
By Ethan Shenkman
"I have upheld agencies in dozens and dozens of cases," insisted now-Justice Brett M. Kavanaugh, parrying questions from Democratic senators accusing him of leading an effort to "rein in" executive agencies.
By Tom Fox
With certain exceptions, this online product safety database covers dangerous non-food products.
By Arnold & Porter Kaye Scholer LLP
CAMBRIDGE, MASS. — Today, sororities, fraternities and students filed a pair of lawsuits challenging a Harvard sanctions policy that punishes students who join off-campus, single-sex social...
By Kristen Ittig, Stuart Turner, Amanda J. Sherwood, Alexandra Barbee-Garrett
The General Services Administration (GSA) currently operates 24 Multiple Award Schedules (MAS), under which it awards largely pre-negotiated contracts on largely commercial-item terms
By Laurie Abramowitz, David Sausen, Reuven Graber
The US Internal Revenue Service and the US Department of the Treasury recently released proposed Treasury regulations (Proposed Regulations) that modify the application of Section 956...
By Dominique Casimir, Ronald Schechter, Alexandra Barbee-Garrett
Contractors generally understand that suspension and debarment carry serious consequences, most significantly, the ineligibility to receive federal contracts.
By Daniel Kracov, Mahnu Davar, Raqiyyah Pippins, Bryant M. Godfrey, Abeba Habtemariam
Virtually all pharmaceutical companies have been exploring the use of various software tools in both drug development and in conjunction with marketed products.
By Declan Tansey
The IRS Form 990 is more than a tax return, it's a public statement about your nonprofit's financial, programmatic and governance activity for the year.
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