The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
&The U.S. Court of Appeals for the Federal Circuit, in BGT Holdings LLC v. United States, 1 recently held that the government does not have the discretion to deny a contractor's request for equitable adjustment (REA) under Federal Acquisition Regulation (FAR) 52.245-1 (Government Property) where the conditions specified in that clause are present and the contractor is able to show financial loss ...
In Joanne Properties Ltd v Moneything Capital Ltd and Anor [2020] EWCA Civ 1541, England’s Court of Appeal had to decide whether the parties had entered into a binding contract of compromise contained in written communications passing between their respective solicitors. The Court below had held that a binding contract had been made, despite the fact that the correspondence in question had been marked “subject to contract” ...
A recent UK Supreme Court Judgment, the Financial Conduct Authority v Arch Insurance (UK Ltd) & Ors [2021] UKSC 1, clarified whether a variety of insurance policy wordings cover business interruption losses resulting from the COVID-19 pandemic and public health measures taken by UK authorities in response to the pandemic from March 2020 ...
The recent judgment from the Supreme Court of the United Kingdom on Halliburton Company v Chubb Bermuda Insurance Ltd [2020] UKSC 48, raised important questions about the requirement that there can not only be no actual bias, but also no apparent bias on the part of arbitrators in favour of or against any party in arbitration and also about the obligation of arbitrators in international arbitrations to make disclosure of multiple appointments concerning the same or overlapping subje
Following the renewal of the state of emergency, Decree 3-A/2021 of14January of the Presidency of the Council of Ministers, determines the closure of various types of establishments. Inthiscontext, the employment support measures were amended by Decree-Law 6-C/2021 of 15 January and Decree-Law 6-E/2021 of15January, which we summarised below. 1 ...
Physicians, physician assistants, and advance practice nurses who have sought to treat opioid-addicted patients with Schedule III-V Controlled Substances that have been approved by the United States Food and Drug Administration for that indication have had to apply for a waiver under the Drug Addiction Treatment Act of 2000. Eligible medications are presently limited to buprenorphine-containing products such as Suboxone and Subutex ...
In December 2018, section 53.1 was added to the Patent Act (the? Act?) Allowing reference to be made to communications exchanged with the Canadian Intellectual Property Office ("CIPO") During the prosecution of an application with respect? [... ] to the construction of a claim.? This concept is more commonly known as? File wrapper estoppel ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
The “right to be forgotten” (“RTBF”) has been central to the global debate over the balance between individual privacy and freedom of information and of the media in recent years. Such right has been affirmed by the European Court of Justice in a milestone case in 2014, as well as later in the UK, although its application in other countries remains uncertain ...
As we continue through Lockdown 3, we are seeing how children can be caught in the middle of family disputes involving separated parents trying to navigate living arrangements between different family bubbles. With that in mind, it appears to be more important than ever within the context of private law children proceedings for the courts and authorities to be alert to the views of the children when determining what should happen ...
The Electronic Communications Code was subject to a wholesale re-write in 2017, with the intention of facilitating the faster roll-out of the UK’s digital communications infrastructure. Three years on, the government has commenced a consultation on proposals to revise aspects of the Code to ensure it is fit for purpose ...
1. Background to the case The case concerned a young, female employee in a mechanical workshop, who felt she had been sexually harassed by two of the enterprise’s customers. Customer No 1 had on one occasion, while the female employee was sitting on the floor in a forward-leaning position, performing work, put his hands on her lower back, under her top ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
The introduction of mandatory pre-installation of applications developed by Russian market players, caused by a wave of cases of abuse by global companies of their dominant position in digital markets, is a significant innovation in Russian antitrust and consumer protection law. To reduce the risks of restricting competition and balance the bargaining power of global corporations with small domestic application developers, amendments to the Law dated February 7th 1992 No ...
In a recent press release, the U.S. Department of Health and Human Services Office of Inspector General (HHS/OIG) announced five additional guilty pleas relating to a $1 billion telepharmacy fraud scheme. However, unlike many health care fraud cases, this particular case was investigated over the course of three years by an interagency team comprised of personnel from HHS/OIG, the U.S. Department of Justice (DOJ), the U.S. Food and Drug Administration (FDA), the U.S ...
In a decision that could be a game-changer for cookie and candy manufacturers, the Third Circuit has recently denied trade dress protection for the shape of the popular Pocky cookie. The Pocky is a long, thin Japanese cookie stick that is almost completely dipped in chocolate, except for the very bottom. Ezaki Glico created the Pocky in 1966 and obtained two trade dress registrations to protect the configuration of the cookie ...
Traditionally, Belgian labour law distinguishes between two forms of telework, namely structural telework, regulated by the Collective Labour Agreement n° 85, and occasional telework, regulated by the Act on Workable and Agile Work. Since the start of the Covid-19 pandemic, a third category has been added, namely 'Covid telework', which was, at a certain point, recommended but has now been made compulsory again by the government ...
Leases often include language that gives a tenant the option to purchase the leased property during or at the end of the lease term. The Michigan Supreme Court has held that these options to purchase, or “options” as they are commonly referred, are “simply a contract by which the owner of the property agrees with another that he shall have a right to buy the property at a fixed price within a specified time ...
Some facts and figures that set out the landscape of merger control, antitrust enforcement and competition litigation in Portugal in 2020. Interim Measures The PCA ordered the Portuguese Professional Football League to suspend its decision preventing teams in the First and Second Football Leagues from signing players that have unilaterally terminated their contracts due to the COVID-19 pandemic ...
Introduction In the recent Industrial Court Award of Harry Wong Wei Chen v Petroliam Nasional Berhad [Award No.11 of 2021] dated 4 January 2021, the Industrial Court upheld the dismissal of an employee (“the Claimant”) on account of several allegations of sexual and workplace harassment. An interesting point in the instant case was the absence of corroborative witnesses in respect of several of the complaints against the Claimant ...
Bradley’s Government Enforcement and Investigations Practice Group is pleased to present the False Claims Act: 2020 Year in Review, our annual review of significant False Claims Act (FCA) cases, developments and trends. Despite the pandemic and the smallest recoveries for the Department of Justice in over a decade, FCA enforcement remains robust. As always, the healthcare industry remains the most frequent subject of FCA cases and investigation ...
When Alabama’s Legislature convenes for its annual session on February 2, lawmakers will once again be asked to consider a bill that would provide certain Alabamians with access to medical cannabis ...
It is common knowledge among many human resources professionals that religious organizations generally are protected from religious discrimination lawsuits under Title VII of the Civil Rights Act and most state anti-discrimination laws. For example, a Baptist organization may apply a preference for members of the Baptist Church in its hiring decisions ...
