FDA Releases Draft Guidances to Promote Clinical Trial Design Efficiency

On September 28, 2018, the U.S. Food and Drug Administration (FDA) released two draft guidances for industry. The purpose, according to FDA Commissioner Scott Gottlieb, M.D., is to modernize the approach to clinical trial design in efforts to (1) make clinical trials more efficient while maintaining patient safety and (2) increase the amount of information concerning product safety and benefits. The two draft guidances are entitled: “Master Protocols – Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics” and “Adaptive Designs for Clinical Trials of Drug and Biologics.” This is the second of the two-part blog series describing the updates to the agency’s recommended approach to incorporating master protocols in clinical trials of new drugs and biological products for the treatment of cancer. The first of the two-part blog series described FDA’s recommended considerations to “adaptive designs” used in clinical trials.

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Financial Services in Focus – Issue 13

Funds and financial products

Corporate Collective Investment Vehicle – tranche three

On 12 October, the Government has released for public consultation the third tranche of the Treasury Laws Amendment (Corporate Collective Investment Vehicle) Bill 2018 and related explanatory materials.

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New Draft Guidance on Adaptive Designs for Clinical Trials

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.

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ILN Today Post

Aanbod voor een huurovereenkomst: kijk een gegeven paard niet in de bek!

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.

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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.”

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How the Section 199A Proposed Regulations Would Affect Businesses

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.

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ILN Today Post

HIPAA wake-up call

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.

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Tax implications of a ‘casual worker’

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).

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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.

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ILN Today Post

Wayfair update: States begin imposing economic nexus rules as Congress mulls federal legislation

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.

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