LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
Our clients from outside the province of Quebec often ask us the following questions: what are the linguistic labelling requirements in Canada, and particularly Quebec? There are several statutes and regulations governing labelling in Quebec and Canada. The following is a summary of some of the major points relating to the use of the French language ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On September 23, Kudun and Partners were invited by TrustLaw, the charitable arm of Thomson Reuters, to be the legal experts in their Legal Health Check Workshop. The core objective of the event was to raise awareness of how law firms, like Kudun and Partners, can work with TrustLaw to provide pro bono legal services to NGOs, Civil Society Organizations (CSOs) and social enterprises (SEs). Chai Lertvittayachaikul and Emi Rowse (Igusa), partners of Kudun and Partners, presented at the event ...
Kocián Šolc Balaštík kicked off the new year by helping complete a significant transaction: the sale of UG Air, an operator of duty free and fashion shops at the international airport in Prague, to Aelia Czech Republic s.r.o. KSB has provided legal advice to UNIMEX GROUP, a.s ...
Author(s) Senior Partner, Nishant Menon and Associate, Nikhil Bhatia The Supreme Court of India on 6th August 2021 in Amazon.com NV Investment Holdings LLC v Future Retail Limited & Others handed down a seminal decision in relation to enforcement of an Emergency Arbitrator’s (“EA”) award. The ruling has great significance as it furthers India’s mission of being a pro-arbitration State where there is greater ease of doing business ...
Kochhar & Co. advised UK-based integrated manufacturing-services and power products company, Volex plc on its acquisition of majority stake in inYantra Technologies Pvt Ltd, an electronics design and manufacturing services company for USD 13 million (approx. INR 100 crore). The transaction entailed subscription to fresh equity issued by inYantra Technologies as also purchase of equity from the existing shareholders, by Volex plc through its Indian subsidiary ...
The Finance Minister Smt. Nirmala Sitharaman envisages a holistic vision of healthcare that translates into wellness of the citizen ...
Many charities occupy property, whether as offices, shops or for other charitable purposes from hospices to food banks ...
We thought the conclusion of a long-delayed inquiry by the Charity Commission into the collapse of the high-profile charity Kids Company would be the last word on this matter, but there may well be another twist... If you’ve followed what has been happening in the charity sector over the last seven years - or even if you’ve just been reading the news in that time - the chances are you’ll have heard of Kids Company and about its spectacular collapse in 2015 ...
On September 8, 2023, the China National Center for Biotechnology Development (the "CNCBD"), a public institution under direct charge of the China's Ministry of Science and Technology (the "MOST"), released the"Notice on Issuing Answers for Frequently Asked Questions on Human Genetic Resource Administration"(the "Updated FAQs"), which summarized and responded to questions that are constantly raised among the relevant industry (the "Industry") ...
On September 7, 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the"NMPA") released "Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022)"(the"2022 Annual Report") ...
On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for int
State efforts to address the 340B Drug Program[1] continue to ramp up in 2024. Early this January, Kentucky Senator Stephen Meredith introduced Senate Bill 27 ("SB-27"), which intends to address a number of purchasing restrictions drug manufacturers unilaterally imposed on health care providers participating in the 340B Program ...
The Federal 340B Drug Discount Program (the “340B Program”) is a budget-neutral drug-pricing program that allows certain hospitals and clinics (“Covered Entities”) to buy discounted medication from drug manufacturers ...
Marks & Spencer breached a court order to enforce a “keep-open” provision in one of its leases, when it carried on business only in a “half-hearted” manner ...
As applications for Module 3 Core Participant (CP) status drew to a close on 5 December 2022, the Inquiry team have announced two key dates, as we continue to monitor progress of the UK Covid-19 Inquiry. No timescales have been given as to when applicants will be informed of the outcome of their CP applications, with the only information provided being that the Inquiry Chair (Baroness Heather Hallett) will be reviewing and determining in 'due course' ...
July 2022 saw the formal commencement of the UK Covid-19 Inquiry. Opened by Inquiry Chair Baroness Heather Hallett, we later witnessed preliminary hearings for Modules 1 and 2, held in October and November. As a reminder, Modules 1 and 2 cover the overarching topics of the UK’s pandemic preparedness and resilience, and core political and administrative decision-making throughout the UK (incorporating sub-modules for Scotland, Wales and Northern Ireland), respectively ...
Recent reports indicate that mental health and well-being have dropped back down the business agenda, despite levels of workplace stress remaining high in the wake of the pandemic. A recent report by the Chartered Institute of Personnel and Development (CIPD) found that many employers are failing to keep mental health and well-being at the forefront of their business agenda despite the lingering impact of the pandemic ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
On the occasion of Children’s Day on January 12, 2023, Kudun and Partners launched an internal donation drive on January 12 to rally firm members to support children’s centers in Bangkok and Hat Yai. The donation drive was initiated as part of the firm’s continuous aspiration to contribute back the society ...
In its conference on Feb. 19, the U.S. Supreme Court is scheduled to consider two pending petitions for certiorari that could resolve a critical but deeply disputed issue that impacts both the False Claims Act and health care law. The cert petitions in those cases — U.S. v. Care Alternatives,[1] and Winter v ...
