IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
ALERT Hospital May Be Excluded For Physician Recruiting On May 8, 2006 the OIG announced that it intends to exclude San Diego-based Alvarado Hospital from participation in Medicare, Medicaid and all other federal health care programs because of payments the Hospital made under relocation agreements involving placement of newly-recruited physicians in established physician practices ...
Certificate of Need Strategies for New Nursing Home Beds Special Population Beds are Re-Approved At its March 2006 meeting, the Michigan Certificate of Need (“CON”) Commission took action to re-approve several state-wide pools of nursing home beds that are set aside to serve special populations, including: Alzheimer’s Use 60 beds Hospice 30 beds Religious Use 20 beds The Commission reserved 22 special population beds on a non-specified basis for future use ...
Although the United Kingdom comprises England, Scotland, Wales and Northern Ireland, this guide relates only to the current position in England and Wales because Scotland and Northern Ireland have their own individual legal systems. The rules and procedure of the Civil Courts in England and Wales are contained in the Civil Procedure Rules (CPR) which were introduced in 1999 and which lay down the framework within which all civil litigation must be conducted ...
On 14 July 2006, the Hong Kong and Mainland China Governments signed a ground-breaking agreement, rather lengthily entitled "An Arrangement on Reciprocal Enforcement of Judgments in Civil and Commercial Matters by the Courts of the Mainland and of the Hong Kong Special Administrative Region pursuant to Choice of Court Agreements between Parties Concerned" (Arrangement), under which they agreed to recognise and enforce judgments made in each others courts ...
It is now eighteen months since Freedom of Information legislation came into force and one of the most interesting facets of the Scottish and UK Information Commissioners' decision-making has been the application of the public interest test. In terms of the Freedom of Information legislation there are certain exemptions which, when they apply, can potentially exclude requested information from disclosure ...
Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
The federal Pipeline and Hazardous Material Safety Administration (PHMSA) has proposed new regulations for rural onshore low stress pipelines and rural onshore gathering lines. Although PHMSA has been anticipating further regulation of these types of lines for the past few years, the Agency acknowledges that the proposed rule is a direct response to legislative and media scrutiny of recent incidents that occurred in the Alaska Prudhoe Bay field ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
The cause of an action in defamation exists to provide some recourse and remedy to victims of falsehoods which can and do cause injury to reputation. In a classic formulation, recently adopted and approved by Geopel J ...
A spectacular smash-up always draws a crowd. In the outsourcing world, where the wreckage is nearly always kept under wraps, that’s even more true. When a problem deal does break into view, it’s always worth watching for lessons in how to manage – or how not to manage – these complex transactions ...
Film Services OfficeThe Film Guarantee Fund (FGF) : First established in April 2003, the FGF’s main objective is to assist local film production companies to obtain loans from financial lending institutions for the purpose of producing films and to help develop a film finance infrastructure in Hong Kong ...
On 14 July 2006, the Hong Kong and Mainland Chinese Governments signed a ground-breaking agreement entitled “An Arrangement on Reciprocal Enforcement of Judgments in Civil and Commercial Matters by the Courts of the Mainland and of the Hong Kong Special Administrative Region pursuant to Choice of Court Agreements between Parties Concerned” (the “Arrangement”), under which they agreed to recognise and enforce judgments made in each others courts ...
In an effort to “rejuvenate the excitement of going to the movies”, The Drive-In became Hong Kong’s first drive-in cinema when its first of 4 screens opened to the public on December 6 2006. The second is tentatively to open by Christmas and the last two, by Chinese New Year 2007 . Situated in the West Kowloon Cultural District, the venture is owned by Sowell Resources Limited who also holds the lease to the site of The Drive-in ...
Another victim of the economic boom in Hong Kong is the Cine-Art Cinema which was officially closed in November 2006. The cinema was the only venue on Hong Kong Island that programmed independent, arthouse films. The only other arthouse cinema is Broadway Cinemateque in Kowloon. Due to rising property prices and a declining audience for several years, Cine-Art had no choice but to close ...
On 17 November 2006, the Beijing First Intermediate Court rejected the copyright infringement claim made by seven music companies, namely Sony BMG, Warner, EMI, Universal, Gold Label, Go East and Cinepoly, against NASDAQ-listed Baidu.com. The music companies which owned the copyright, alleged that the MP3 search service of Baidu.com allowed users to freely download 137 songs and sought an injunction as well as damages in the amount of RMB1,690,000 ...
The war between new DVD technologies, Blu-ray and HD DVD are reminiscent of the battle between the VHS and Betamax videocassette formats. Who will be the winner in this war is yet to be seen as these formats are now becoming available in retail outlets. Supported by Sony, Blu-ray is the next generation optical disc which was developed to store large amounts of data and to enable recording, rewriting and playback of high definition (HD) video ...
In our July 2006 legal update, we reported on a ground-breaking agreement (Agreement) signed by the Hong Kong and Mainland China Governments, under which they agreed to recognise and enforce judgments made in each others courts. Legislative changes are now underway in Hong Kong in order to implement the Agreement ...
During the last 10 years there has been a significant market debate about the position Chile should take in connection with open digital television. This debate is all teh more significant because this service may predominate in the future because of its ability to allowing users to better administer the content they wish to watch. Since the beginning of the debate, different countries have tried to introduce their respective technologies in Chile ...
Advocate General Sharpston has recently expressed her opinion in the Commission v Republic of Finland case that ensuring a sufficient degree of transparency for the award of sub-threshold procurements should be determined by national law, rather than Community law. If these views were to be followed by the ECJ, it would provide renewed impetus to create national rules on low value awards and represent a meaningful evolution of the ECJ's past case law ...
The U.S. Department of Justice’s revised corporate charging policy, which was named after deputy attorney general Paul McNulty, was unveiled in December 2006. In the wake of its predecessor document, the 2003 Thompson Memo, we have seen a steady increase in the resolution of corporate criminal investigations without indictments or trials ...
A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...
The purposes of this Health Care Alert are to: 1) summarize recently proposed federal regulations which will require physician disclosure of ownership interests in hospitals to patients; 2) remind health care providers of existing Texas laws requiring disclosure of ownership interests and 3) suggest best practices for disclosure of ownership interests ...
On Capitol Hill, U.S. lawmakers are considering legislation that would authorize the U.S. Food and Drug Administration (FDA) to approve generic versions of biological products. Representative Henry Waxman (D, CA), of “Hatch-Waxman” fame, has introduced the “Access to Life Saving Medicine Act” (H.R. 1038) to advance this change to U.S. law. In introducing the legislation, Rep ...
