On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
As per Notification No. 039 issued by the Ministry of Economy and Finance (MEF) on 21 July 2016, a working group consisting of representatives from both the General Department of Taxation (GDT) and the Phnom Penh Municipality will begin to collect data from all enterprises in Phnom Penh from August 2016 onwards. Representatives of the working group will physically visit all enterprises in Phnom Penh for the purpose of: 1. Gathering the enterprise’s statistics; 2 ...
On December 1, 2005, the second paragraph of section III of Article 31 of the Income Tax Law became effective and requires taxpayers seeking to deduct the purchase of gasoline to pay with the taxpayer’s check payable to the seller, with a credit, debit or services card, or with a prepaid card, authorized by the Tax Administration Service. On January 25, 2006 a new amendment to Rule 3.4 ...
A GAO report was intended to shed some light the use of captives as abusive tax shelters. Instead it only risks perpetuating misunderstandings, says Bradley’s Davis Smith ...
In the fourth quarter of 2023, Sen. Raphael Warnock, D-Ga., made industry news, important banking and financial rule changes were implemented, and Georgia's Department of Banking and Finance quietly issued important new regulatory guidance on a handful of topics. Warnock Addresses Banking Committee, Introduces Legislation First, during a three-plus hour U.S ...
The government are set to introduce new measures on High in Fat, Salt and Sugar (HFSS) food including restrictions on volume offers and new rules on placement and promotion. What is a HFSS food? HFSS foods are food or soft drink products that are assessed as high in fat, salt or sugar in accordance with the Department of Health nutrient profiling model. Foods scoring 4 or more points and drinks scoring 1 or more are classified as HFSS ...
The UAE continues to implement new measures on a daily basis to curb the spread of COVID-19. Those measures are being adopted, announced and implemented at a very rapid pace. For ease of reference, we present here a summary of the key measures that have been implemented by various UAE authorities between 18 March 2020 and the time of this inBrief, 9:00 a.m. on Friday, 3 April 2020 ...
IRS Announcement 2017-15 provides relief to employees who have been adversely affected by the recent wildfires in Northern California by allowing them to take loans or distributions from retirement plans to alleviate hardships caused by the wildfires. The Announcement also provides relief from verification procedures required under retirement plans with respect to loans and hardship distributions ...
Is the unitary business principle the sole test for determining whether a state can tax an apportioned share of a non-domiciliary’s capital gains under the U.S. Supreme Court’s Due Process Clause and Commerce Clause jurisprudence? Jaye A. Calhoun, Bruce P. Ely, and Kelvin M. Lawrence believe so, and discuss its relevance in the last of a two-part series focusing on a closely watched case currently on appeal before the Massachusetts Supreme Judicial Court ...
On November 12, 2020, the Federal Trade Commission (FTC) sued to block the acquisition of two Memphis-area hospitals by Methodist Le Bonheur Healthcare. Eleven months earlier, on December 12, 2019, Methodist entered into an agreement with Dallas-based Tenet Healthcare Corporation to purchase Saint Francis-Memphis and St. Francis-Bartlett (along with their associated physician practices, urgent care centers, and other ancillary care providers) for $350 million ...
For several years, pursuant to the Food Drug and Cosmetic Act and Federal Trade Commission Act,[i] the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued joint warning letters to CBD companies alleging labeling claims they made are false or misleading. According to the agencies, the claims being made by these CBD companies include assertions that their CBD products will treat or cure serious health conditions ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
Southwest Health Alliance (“Southwest”), an independent practice association with approximately 900 member-physicians, has agreed to a proposed order recently entered by the Federal Trade Commission (“FTC”) settling charges that it engaged in anticompetitive conduct in its dealings with insurers and other payors for the provision of physician services (collectively, “insurers” or “payors”) ...
This year, the Federal Trade Commission (the “FTC”) and the Department of Justice (the “DOJ”) have been modifying antitrust guidance related to healthcare, and recently enacted three notable changes. First, the FTC and DOJ jointly issued updated Draft Merger Guidelines (the “Draft Guidelines”) to address the way the agencies evaluate a merger to determine its effect on competition ...
Activists are recasting risk in a way that can only damage industry Last August, a California jury awarded plaintiff Eva Echeverria a total of $417m in compensatory and punitive damages in a lawsuit against Johnson & Johnson (J&J). Her case was that the company should have warned consumers that studies had found an inconclusive correlation between ovarian cancer and talcum powder ...
April 17, 2023 By: Meghna Parikh ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients ...
Attacks by the South African Revenue Service (“SARS”) on the transfer pricing practices of multinational enterprises (“MNEs”) are on the rise, leading to tax disputes with SARS over significant amounts of tax. MNEs operating in South Africa provide information to SARS in various forms such as annual Corporate Income Tax returns, Country-by-Country reports as well as the extensive Transfer Pricing documentation ...
The designation of eight new Freeports within England made headlines in the Budget and now the winning bidders have to put into effect their successful proposals. What will this mean in practice for those areas affected and what are the likely issues that Freeport authorities will face? We have pulled together some questions we are asked frequently on Freeports, together with the responses we have been providing to our clients ...
It is evident that the current lockdown is having an unprecedented slowdown in the movement of persons between EU Member States. This is not due to a restriction which was imposed by the EU itself but because of the restrictions which the Member States themselves imposed through their respective Public Health officials. It is noticeable that the legal restrictions on immigration were driven by the Member States' individual rules rather than by a general guideline from the EU ...
The HHS Office for the National Coordinator of Health Information Technology issued an interim final rule on October 29, 2020, extending the compliance date for the information blocking rule under the 21st Century Cures Act to April 5, 2021 ...
