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International Lawyers Network

The International Lawyers Network (ILN) is a leading association of 91 high-quality, full-service independent law firms.

Since 1988, the ILN has helped its members keep pace with today’s global economy, through access to the tremendous strength and depth of the combined expertise of 5,000 lawyers in 66 countries on six continents.

ILN member firms are among the most respected and most experienced counsel in their jurisdictions. Clients’ increasing need for reliable foreign counsel is well-met by the personalized, high-quality and cost-effective legal services provided by ILN member firms. Unique to the ILN are the strong personal and professional relationships among its members and their clients developed over the past 30 years. Far from a mere directory, the ILN is an affiliation of lawyers who gather on a regional and worldwide basis annually and work routinely with each other to address client requirements and needs.

Each of the ILN’s member firms is international in outlook and staffed by highly trained senior attorneys, who are experts in a broad range of practice areas. ILN members have demonstrated experience in working successfully with international companies. They are independent, mid-sized firms within their jurisdictions, and are committed to the focus of the International Lawyers Network, admitted to the Network only after a rigorous application process. The ILN provides clients with high-quality service from experienced local counsel who work in firms that maintain excellent reputations in their own countries. This means that clients have immediate access to attorneys who are native, both linguistically and culturally, to the country of interest.

The ILN’s international directory app is available for iPhone, Android and BlackBerry smartphones. To access the app, click here or log on to ILNmobile.com from your smartphone.

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ILN Today Post

Will the FTC Match DOJ’s Efforts to Speed Up Merger Reviews?

On October 3, 2018, at a hearing before the U.S. Senate Subcommittee on Antitrust, Competition Policy, and Consumer Rights (“Hearing”), Makan Delrahim, the Assistant Attorney General for the Antitrust Division of the Department of Justice (“DOJ”), announced efforts by DOJ to “modernize and speed up the process of merger review.” Among other things, DOJ stated that it would endeavor to resolve most merger investigations within six months of filings. Relatedly, DOJ plans to make modifications to its second request process, including reforms to its timing agreements with merging parties.

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New Federal Laws Banning “Gag Clauses” in the Pharmacy

On October 10, 2018, President Donald Trump signed into law the “Know the Lowest Price Act” and the “Patients’ Right to Know Drug Prices Act,” which aim to improve consumer access to drug price information by banning gag clauses. The Trump administration previously announced its intention to enact this legislation in its May 2018 Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs and will likely point to these new federal laws as affirmation of its commitment to drug pricing reform that favors patients and consumers.

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Talking Tax – Issue 138

Case law

Overseas services provided to Australians subject to Australian tax

In Satyam Computer Services Limited v FCT [2018] FCAFC 172, the Full Federal Court upheld a decision that payments received for services provided to Australian customers by Indian based employees of an Indian company are deemed to have an Australian source and are therefore assessable in Australia.  The Court held that this was not double taxation, even though the payments were also royalties under the Australia-Indian DTA (Indian Agreement).

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New rights for casual employees – what you need to know

From 1 October 2018 new rights that apply to casuals have come into effect which employers should be aware of.

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FDA Addresses Allegations of “Gaming” The Generic Drug Approval Process Through The Use of Citizen Petitions

On October 2, 2018, FDA Commissioner Scott Gottlieb released a statement announcing new agency actions to further deter “gaming” of the generic drug approval process through the use of citizen petitions.  Among these actions, the most significant was the issuance of a revised draft guidance on citizen petitions subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), published on the same day.  The stated goal of this revision was to create a more efficient approach to 505(q) petitions and to allow the Agency to focus reviewer resources on scientific reviews.

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OCR and ONC Update Their Security Risk Assessment Tool

On October 16, 2018 the Department of Health and Human Services Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) announced an update to their previously provided Security Risk Assessment Tool.  According to ONC and OCR, the “tool is designed to help healthcare providers conduct a security risk assessment” as required under the HIPAA Security Rule.  ONC states that the updated tool includes additional features such as:

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20 Davis Malm Attorneys Recognized by Massachusetts Super Lawyers

Davis Malm is pleased to announce that 20 of its attorneys were named to the list of 2018 Massachusetts Super Lawyers and Rising Stars. The results will be published in Boston magazine and in New England Super Lawyers, which is published by Thomson Reuters.

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FDA Issues Draft Guidance on Management of Cybersecurity in Medical Devices

The FDA issued a new Draft Guidance today to ensure medical devices – an increasing potential target for hackers – are better protected from unauthorized digital access.

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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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