On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."1 The draft guidance describes FDA’s views on defining, establishing and documenting the responsibilities of parties that are involved in the contract manufacturing of drugs that are subject to current good manufacturing practice (cGMP) requirements ...
Dear Reader, We have the pleasure to present the new edition of Doing Business in the Baltics. We hope that the information presented in this publication will provide businesses, investors and their advisers a better understanding of the advantages that the Baltic States have to offer ...
As previously described, in the fall of 2012 the NYSE and NASDAQ markets previously issued rules concerning the independence of compensation committee members and advisers as required by the Dodd-Frank Wall Street Reform and Consumer Protection Act. These rules were approved by the Securities and Exchange Commission in January 2013 ...
After the Netherlands, Slovakia, and the UK, it is now France’s turn to impose Sunshine-like obligations on the pharmaceutical industry. Soon, similar obligations will apply to all EU countries, after EFPIA, the European trade association for the pharmaceutical industry, adopts a code of conduct on disclosure of transfers of value between pharmaceutical companies and health care professionals or institutions ...
On April 11 2013, the Philippine Bureau of Internal Revenue issued Revenue Regulations No 6-2013 (RR 6-2013) amending certain provisions of Revenue Regulations No 6- 2008, which provides for, among other things, therules involving the determination of the fair market value of shares of stock not listed and traded in the local stock exchanges ...
The Turks & Caicos Islands (TCI) has recently introduced a raft of legislation to enhance its existing comprehensive anti-money laundering regime. The provisions largely follow the “Review of Financial Regulation in the Caribbean Overseas Territories and Bermuda” recently conducted for the British Government by KPMG (generally known as “the KPMG Report”) ...
The Budget. The 83rd Texas Legislative Session convened on January 8th with news of a better-than-anticipated revenue estimate, an unusually high number of new and second-term legislators, and less controversy and fanfare than observers have come to expect at the start of the biennial, 140-day process. In mid-March, only days before the bill became due, lawmakers passed and the Governor signed legislation to fill the $4 ...
Canada’s new anti-spam law (the CASL) is expected to come into force later this year. This Act is designed to create a safer online environment for individuals and businesses in Canada. From a business perspective, it will change how some routine daily activities – such as distributing commercial electronic messages (CEM) to customers – are executed. Currently, a majority of businesses rely on implied consent when they send CEM to customers ...
In 2012, the National Labor Relations Board (NLRB) set the business community atwitter when an administrative law judge in American Red Cross decided that an at-will disclaimer in an employee handbook violated the National Labor Relations Act (NLRA) by being overly broad ...
America’s high school and college students will soon be finishing another school year, and employers across the country are gearing up to welcome many of these young adults as interns for the summer. Interns are staples in many organizations and often provide valuable benefit to a business. As employers strive to keep costs down, including that of labor, many use unpaid summer help where possible ...
Earlier this month, the United States Department of Justice (“DOJ”) filed a suit against Vitas Hospice Services, L.L.C. and its subsidiary entities (“Vitas”) alleging that Vitas submitted false claims for hospice services which were excessive, unnecessary, or not provided, and also alleging that Vitas admitted patients to hospice who were not terminally ill ...
On February 25, 2013, the Department of Health and Human Services (HHS) released its final rule (the Final Rule) setting forth standards for health insurance issuers under the Patient Protection and Affordable Care Act (the Affordable Care Act). Specifically, the Final Rule outlines exchange and issuer standards related to coverage of essential health benefits, minimum value and actuarial value ...
Last month, the United States Supreme Court (Supreme Court) provided an unexpected gift to entities facing collective actions under the Fair Labor Standards Act (FLSA) by holding that defendants may moot such a case by making an offer of judgment pursuant to Rule 68 of the Federal Rules of Civil Procedure. This ruling could have application to the more common vehicle for multiple plaintiff claims, class actions under Rule 23, but that has yet to be tested ...
Because of recently-enacted changes to the West Virginia Wage Payment and Collection Act, West Virginia employers will have more time to pay final wages to discharged employees. Prior to this change, the Wage Payment and Collection Act required that employers pay discharged employees within 72 hours of termination ...
Last week, a federal jury in South Carolina found that Tuomey Healthcare System, Inc. violated the Stark Law and the False Claims Act by submitting false claims for reimbursement to the United States, resulting in $39 million in damages to the government. United States ex rel. Drakeford v. Tuomey Healthcare Sys., Inc., No. 3:05-2858-MBS (D.S.C. May 8, 2013) ...
1. OverviewIn accordance with theWorld Football Association’s, FIFA’s requirements, (consistent) time periodsfor the transfer of players have been established within the Union of EuropeanFootball Associations (UEFA). These time periods exist to ensure that the transferwindows of individual Football Associations coincide with each other and inturn to guarantee equal opportunities for each individual club ...
It is expected that Canada's new Anti-Spam Legislation (CASL) will come into force later this year, and with it will come significant changes for how businesses and individuals may send people "commercial electronic messages" (CEM), including emails or text messages.CASL aims to create a safer online environment by targeting issues relating to spam, such as unsolicited commercial messages, phishing and unauthorized installation of software ...
On April 24, 2013, WorkSafeBC announced the approval of new Occupational Health and Safety Workplace Bullying and Harassment Policies, which come into effect on November 1, 2013 ...
Following a month-long retrial, a South Carolina jury has concluded that Tuomey Healthcare System, Inc. (Tuomey) violated the Stark Law and the False Claims Act by illegally paying referring physicians. The jury found that Tuomey’s compensation arrangements with referring physicians were impermissible under the Stark Law, resulting in almost 22,000 false claims and more than $39 million in overpayments ...
Today the HHS Office of Inspector General (OIG) issued an Updated Special Advisory Opinion addressing the recommended scope and frequency of exclusion checks of employees and contractors. The Advisory Opinion provides important and practical guidance to assist healthcare providers seeking to protect their businesses against the risk of employing or contracting with excluded individuals and entities ...
It is undeniable that technology and globalization are changing the way lawyers practice law. Technology has not just made people, places, and things much more accessible to us – it has impacted the way we store information and documents, the way we communicate with and advise clients, how we conduct investigations, and how we participate in discovery ...
If your company utilizes temporary workers supplied by a staffing agency, you may be a target of OSHA. On April 29, 2013, the Deputy Assistant Secretary of OSHA, Richard Fairfax, issued a memorandum to its Regional Administrators, entitled “Protecting the Safety and Health of Temporary Workers.” Mr ...
The National Labor Relations Board (NLRB) has become active in scrutinizing and striking down employers’ social media policies. Three times in the last year, the NLRB issued Operations Management Memoranda providing employers with direction on drafting and applying social media policies. The NLRB specifically evaluated social media policies to determine whether they violated the employee bill of rights in Section 7 of the National Labor Relations Act (NLRA) ...
