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 ...
The Minister of Communication and Informatics (“MOCI”) has finally issued MOCI Regulation No. 5 of 2020 on Electronic System Organizers (“ESO”) in the Private Sector (“MOCI Regulation 5/2020”) that serves as the new implementing regulation of Government Regulation No ...
On 30 December 2020, Bank Indonesia issued Bank Indonesia Regulation No. 22/23/PBI/2020 of 2020 on Payment Systems (“Payment Systems Regulation”). The Payment Systems Regulation is intended to serve as an “umbrella” regulation that provides a regulatory framework for the Indonesian payment systems industry. This regulation will come into force on 1 July 2021 ...
On 4 January 2021, the President of Republic of Indonesia issued Regulation No. 2 of 2021 on the Ratification of the Convention Abolishing the Requirement to Legalize Foreign Public Documents (“PR 2/2021”) (the convention is hereinafter referred to as the “Apostille Convention”). The Apostille Convention was concluded on 5 October 1961 and is intended to simplify a series of formalities for documents signed overseas for the contracting states ...
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 ...
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 ...
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
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 ...
Early last year the Prime Minister dropped the “E-bomb” on British motorists, announcing a ban on cars powered wholly by petrol and diesel from 2030, and on the sale of new hybrid vehicles with the capability to drive a significant distance with zero emissions (such as plug-in or full hybrids) from 2035. Since then, the COVID-19 pandemic has impacted the world in an unprecedented manner ...
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 ...
On February 1, 2021, the Federal Trade Commission (FTC) announced its revised annual threshold that determines whether companies may be required to notify federal antitrust authorities about a proposed merger or acquisition due to the size and value of the transaction. For the first time since 2010 and a reflection of the state of the economy, the annual threshold has been reduced rather than raised, from $94 million in 2020 to $92 million for 2021 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
