The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...
Moving faster than many expected, the National People’s Congress of China promulgated the amended Food Safety Law (“2015 Food Safety Law”) on April 24, 2015. The 2015 Food Safety Law will be effective on October 1, 2015. The 2015 Food Safety Law is regarded as the most stringent food safety regulation in the history of China ...
Since the FDA issued the final menu labeling rule last December, franchisors have been asking what their role and liability is within the framework created by the FDA. In spite of years of FDA consideration and extensive input from industry, food establishments that are subject to the rule remain uncertain about how to comply with its requirements. In addition, the FDA has said very little about how it will enforce the rule To read the full alert, click here ...
In a decision rendered on April 30, 20151, the Administrative Tribunal of Québec (the "ATQ") upheld a decision of the board of directors of a university hospital centre that refused to renew the status and privileges of a physician who failed to fulfill the obligations associated with the enjoyment of these privileges. Firstly, it should be noted that the applicant's clinical competence was not questioned in this case ...
What Is the Size of the Market and What Are Current Trends in Switzerland? Life Sciences is one of the most dynamic and most rapidly growing sectors in Switzerland with respect to both the industrial and the academic dimension. In 2013, the total financ-ing volume amassed by Swiss biotech companies more than doubled compared to the previous year’s figure, reaching USD 325 million, which amounts to an increase of 112% ...
Heightened concerns over recent National Labor Relations Board (“NLRB”) complaints authorized against McDonald’s, USA, LLC—which threaten to undermine the common understanding of a franchisor-franchisee relationship and expand the definition of “employer”— caught the eye of Texas legislators during the recently concluded 84th Regular Texas Legislative Session ...
A wave of settlements with municipal underwriting firms under the SEC’s Municipalities Continuing Disclosure Cooperation (MCDC) Initiative has brought renewed attention to continuing disclosure obligations in municipal offerings. But, it also raises questions about the initiative’s purportedly favorable settlement terms. On July 18, 2015, the SEC announced settlements with 36 municipal underwriters for willfully violating Section 17(a)(2) of the Securities Act ...
On June 6th, 2015, Law No. 20,850, which creates the Financial Protection System for Diagnostics and Treatment of High Costs, and pays posthumous tribute to Luis Ricarte Soto Gallegos, has been published. This law creates a financial protection system for diagnostics and high cost treatments which will be defined by the Ministry of Health by means of a Supreme Decree ...
Directors’ liability for payroll withholding taxes Due diligence: An evolving standard To what risks of liability or being found guilty are directors exposed? Environmental liability of directors and officers DIRECTORS’ LIABILITY FOR PAYROLL WITHHOLDING TAXES Luc Pariseau and Audrey Gibeault
Recently adopted regulations from the Securities and Exchange Commission (the “SEC”) came into effect on June 19, 2015, facilitating qualifying companies’ access to capital and providing investors with additional investment choices. Commonly referred to as Regulation A+, the regulations amend and expand the exemption for smaller public offerings under Regulation A (Rules 251 to 263 under the Securities Act of 1933, as amended (the “Securities Act”)) ...
Internal investigations conducted by enterprises in-house when irregularities are suspected offer many advantages to businesses compared to initiatives undertaken by public law enforcement authorities ...
On April 21, 2015, the State Council of China (i.e. the central government) adopted the proposed draft of Administrative Measures on Concession of Infrastructure and Public Utilities Projects (the “Infrastructure Measures”) ...
Merger control in Ukraine: overviewRegulatory framework1. What (if any) merger control rules apply to mergers and acquisitions in your jurisdiction? What is the regulatory authority?Regulatory frameworkMergers and acquisitions, as well as establishment of an undertaking and appointments to corporate positions under certain circumstances, are subject to merger control in Ukraine ...
The Securities and Exchange Commission (“SEC”) touted 2014 as a record year for its enforcement program and noted cases that spanned the spectrum of the securities industry. Actions against municipal securities issuers and underwriters particularly stand out among the many areas of aggressive enforcement in 2014 ...
The Wills and Probate Registry in the Dubai International Financial Centre (the “Registry”) opened in late April of this year. It is now possible to register a will in Dubai, and to have a high degree of confidence that it will be enforced in accordance with its terms. Prior to the establishment of the Registry, it hadn’t been possible to be so confident that foreign wills would be enforced in the United Arab Emirates ...
The SEC’s Division of Investment Management issued a guidance update last week reminding registered investment advisers and registered investment companies of the importance of cybersecurity and providing recommendations on specific measures that advisers and investment companies should consider in addressing their cybersecurity risks. Last week’s guidance update demonstrates the SEC’s continued focus on cybersecurity as part of its compliance initiatives ...
The Securities Exchange Commission (“SEC”) is continuing to promote its whistleblower reward program and recently announced awards to two individuals who provided key information leading to successful SEC enforcement actions. One whistleblower, a compliance officer, will receive an award of approximately $1.5 million. The other whistleblower, a former head trader, will receive a maximum payout of 30 percent of the amounts collected (which totals over $600,000) ...
Last week the U.S. Department of Justice’s Cybersecurity Unit (“DOJ”) issued guidance to organizations concerning preparing for, responding to, and remediating cyber incidents. DOJ based its publication on lessons learned by federal prosecutors who handle cyber investigations and prosecutions, as well as feedback from private sector victims of cyber attacks and intrusions ...
In recent enforcement actions, the Consumer Financial Protection Bureau (CFPB) sued four payment processing companies – not for engaging in illegal debt collection – but rather, for ignoring warning signs in processing payments for debt collectors who were engaged in fraudulent debt collection schemes. The CFPB charged the payment processors with violating 12 U.S.C ...
In recent years, representation and warranty insurance has gained popularity as a tool to decrease transaction liability exposure in M&A transactions. These policies can be particularly useful in the context of cross-border transactions, for both financial and strategic parties, to facilitate middle-market transactions involving foreign buyers or sellers of domestic U.S.-based businesses. The product is also beginning to gain traction in transactions outside of the United States ...
Target Corporation recently announced that it entered into a settlement agreement with MasterCard International Incorporated, agreeing to pay up to $19 million to MasterCard for payments to reimburse issuing banks for card-replacement and fraud losses allegedly associated with the 2013 data breach at Target ...
In a judgment handed down on January 30, 2015, the Court of Québec held that the failure to respect the prescribed time limits or the violation of a patient’s fundamental rights and freedoms does not lead to the automatic exclusion of a psychiatric examination report concluding that the patient should be confined ...
SyCipLaw Partner Rose Marie M. King-Dominguez and Senior Associate Franco Aristotle G. Larcinacontributed to the Philippine section of the Asia-Pacific Property Investment Guide, a publication produced by Ashurst Australia and Jones Lang LaSalle ...
On April 10, 2015, the Texas Medical Board (“TMB”) voted in favor of adopting amendments to the rules governing telemedicine. The revised rules, which will significantly limit the ability to treat patients via telephone and video consultation, take effect June 3, 2015. TMB took its first steps to curb telemedicine in January 2015 by passing an emergency measure that prohibited prescribing drugs without an initial in-person visit ...
There are two reasons why Latin American clients keep coming to US law firms to handle their cross-border M&A deals. The first reason is our execution capabilities: US law firms have been advising on cross-border M&As for more than 100 years. The second reason is the predictability of a tried and tested legal system: US law remains the preeminent choice for large cross-border M&A deals because of the certainties and guarantees it offers to everyone involved ...
