Two draft guidances issued together late last month seek to increase both clinical trial efficiency and the amount of information that is available about a drug’s safety and benefits. The two draft guidances address, respectively, adaptive designs and master protocols. This blog post discusses FDA’s recommendations for adaptive designs; master protocols will be addressed in a subsequent blog post.
Monthly Archives: October 2018
De gemeente Epe heeft jarenlang een standplaatsvergunning verleend en wenst hieraan een einde te maken. Kan dit zomaar? Deze vraag werd aan het Gerechtshof Arnhem-Leeuwarden voorgelegd. Op 10 juli 2018 heeft het Gerechtshof uitspraak gedaan.
Davis Malm Attorneys Serve As Contributing Authors for ILN’s 2018 Edition of “Establishing a Business Entity: An International Guide”
Davis Malm is pleased to announce the release of the International Lawyers Network’s (ILN) fifth edition of their corporate guide, “Establishing a Business Entity: An International Guide.” This collaborative electronic guide offers a summary of key corporate law principles in 40 countries across the globe, serving as a quick, practical reference for those establishing an entity in these jurisdictions. The firm’s attorneys served as co-authors for the chapter on “Establishing a Business Entity in the United States.”
On August 8, 2018, the Internal Revenue Service (IRS) released proposed regulations (REG-107892-18) that address the operation and calculation of the 20% deduction for qualified business income (QBI) under newly enacted Section 199A of the Internal Revenue Code (the “Code”). These proposed regulations would apply to a domestic business operated as a sole proprietorship, partnership (including a limited liability company taxed as a partnership), S corporation, trust, or estate.
Physician practices, like other HIPAA-covered entities, face a daunting array of threats to their patient protected health information (PHI) and must be diligent when protecting the privacy and security of their records.
In a recent decision, the Full Court of the Federal Court has found that a ‘fly-in fly-out’ worker (Mr Skene) was not a casual worker for the purposes of the Fair Work Act 2009 (Fair Work Act).
The boom in natural gas liquids described in a recent report by the U.S. Department of Energy means good news for states in Appalachia and the Northeast.
The boom in natural gas liquids described in a recent report by the U.S. Department of Energy means good news for states in Appalachia and the Northeast where natural gas production is expected to continue to expand by 200 percent over a 10-year period through 2023.
Effective Oct. 1, 2018, economic nexus rules take effect for remote sellers in 11 states, including Alabama, Illinois, Indiana, Kentucky, Michigan, Minnesota, New Jersey, North Dakota, Washington, and Wisconsin. That means that remote sellers must begin collecting sales tax in these states if they meet the state’s economic nexus threshold, whether they have a physical presence in the state or not.
Despite provisionally agreeing to settle an ongoing dispute with the Securities and Exchange Commission (SEC) centering on a tweet speculating that Tesla may be taken private, Elon Musk has continued to jeopardize settlement discussions by taunting the SEC on Twitter. Given that the terms of any settlement are subject to judicial review, Musk’s Twitter usage has risked exposing Tesla and Musk, personally, to additional monetary liability and further mandates to change Tesla’s corporate structure to limit Musk’s control over the company.