On April 30, 2021, the U.S. Food and Drug Administration (FDA) announced it was revoking a policy related to new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The FDA stated that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
The Ohio Board of Pharmacy recently announced it will award up to an additional 73 dispensary licenses across Ohio. Dispensary licenses will be awarded through an application and lottery process that is expected to be finalized during the spring or summer of 2021. This expansion will bring the total number of dispensary licenses in Ohio to 130 and is expected to ameliorate patient dissatisfaction with regards to the price of medical marijuana products and lack of equal access ...
The Department of Justice (DOJ) suffered an unusual defeat when its motion for late intervention in a False Claims Act (FCA)[1] qui tam case, United States ex rel. Odom v. Southeast Eye Specialists, PLLC,[2] was rebuffed by the Middle District of Tennessee, rejecting the magistrate judge’s recommendations ...
General about enterprise penalty In relation to the previous section on enterprise penalty as enshrined in section 48a of the 1902 Penal Code, discussion were had as to whether there was a requirement of Fault-based liability in the provision. In the preparatory work on section 27 of the new Penal Code, this was discussed in depth, after which it in Ot.prp. no. 27, 90 (2003-2004) s. 242 was clearly stated that the new provision should not have such a requirement ...
For some years, contractors and subcontractors have been using an effective tactic in adjudication. That is to pick off discrete elements of a large time or money claim and to obtain a series of favourable declarations in adjudications on those elements. The declarations can then be used as a bargaining tool to leverage a settlement of the full claim. Or they can be converted into payment orders by way of a further adjudication ...
The government is consulting on a proposal to introduce a new UK-wide tax for residential property developers from 2022, with a view to generating revenue to cover the costs associated with the removal of unsafe cladding. The measure is intended to generate at least £2 billion over the course of a decade, which the government says is a “fair contribution” to the overall cost of the remediation programme ...
In a recent case, the Upper Tribunal decided that land benefitting from a restrictive covenant was greater than the land which had the legal benefit. An application to release the covenant was, accordingly, refused ...
The pandemic has, if nothing else, demonstrated how much more needs to be done in the battle against climate change. Despite the worldwide economic slowdown and travel ban resulting from coronavirus, global carbon dioxide emissions reduced by just 6% (approximately 2.3bn tonnes) in 2020. But both governments and industry are responding to the challenge, however, with a renewed sense of urgency and collaborative spirit ...
We all need our town centres. But more than that, we need our town centres to work better for us. As consumers grow increasingly comfortable with online shopping, the realisation that our towns are over-reliant on retail is being played out at a national level. No longer can we expect empty retail units to be snapped up by new tenants in a matter of weeks ...
Background Disqus is an American company offering online public comment sharing services. These services were previously used by various Norwegian online newspapers. The Data Protection Authority has investigated whether Disqus has been sharing information about the users of the comment sections with marketing companies, without the knowledge of neither the users nor the owners of the online newspapers, and in breach of the GDPR ...
On January 6, 2021, the Small Business Administration (the “SBA”) and the Department of Treasury released an Interim Final Rule called “Business Loan Program Temporary Changes; Paycheck Protection Second Draw Loans” (“Second Draw Rules”). These rules announced the implementation of section 311 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the “Economic Aid Act”) ...
The COVID-19 pandemic has presented many novel challenges and questions for employers, from administration of Families First Coronavirus Response Act (“FFCRA”) leave to managing performance of remote workers. For healthcare providers, these challenges and questions have been only one of many burdens of operating during a pandemic. As vaccines become more widely available, the pandemic raises new challenges, some unique to employers in the healthcare industry ...
Unpacking the Economic Aid Act and American Rescue Plan Act: Consolidated First Draw PPP Interim Final Rule, New First Draw PPP Loans, and Increases to First Draw PPP Loans On January 6, 2021, the Small Business Administration (the “SBA”) and the Department of Treasury released an Interim Final Rule called “Business Loan Program Temporary Changes; Paycheck Protection Program as Amended by Economic Aid Act” (sometimes referred to as the “Consolidated First D
On January 6, 2021, the Small Business Administration (the “SBA”) and the Department of Treasury released an Interim Final Rule called “Business Loan Program Temporary Changes; Paycheck Protection Second Draw Loans” (“Second Draw Rules”). These rules announced the implementation of section 311 of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (the “Economic Aid Act”) ...
The recent anti-suit injunction decision in Axis v Absa Group demonstrates the importance of considering the practical effect of jurisdiction clauses when a suite of contracts or (re)insurance policies are entered into ...
With the purpose of improving the Industrial Property system in Chile, in July 2018, the Government entered a bill that sought to partially modify Law No. 19,039 on Industrial Property and Law No. 20,524, which creates the National Institute of Industrial Property (the “ Project ”). After overcoming several stages, Congress communicated its definitive approval of the Project on April 20 th , 2021 ...
On 29 April 2021, following the release of the widely commented European Commission Guidance on Art. 22 of the EU Merger Regulation (EUMR), the Luxembourg Competition Council published a statement on the recent policy change ...
On June 26, 2021, the Ministry of Economy and Finance – MEF published in the Official Gazette “El Peruano” the Supreme Decree Nº 162-2021-EF (hereinafter, the “Supreme Decree”), whereby it amends the rules contained in the Regulations of the State Procurement Law, adopted by Supreme Decree Nº 344-2018-EF (hereinafter, the “Regulations”) ...
Bio-Rad Laboratories, Inc. v. International Trade Commission, Appeal No. 2020-1785 (Fed. Cir. Apr. 29, 2021) The Federal Circuit’s only precedential patent decision this week comes on appeal from the International Trade Commission, where an Administrative Law Judge found infringement of multiple patents and the Commission issued a limited exclusion order related to sample preparation ...
President Biden has signed into law the FASTER Act, which adds sesame as a "major food allergen" under the Food Drug and Cosmetic Act (FD&C Act). Under the FD&C Act, food labels of products containing sesame, whether in whole seed form or as an ingredient in a spice or flavor, must disclose its presence using its plain English name. The law will become effective on January 1, 2023 ...
Key Points The California Court of Appeal has issued the first published opinion interpreting California Senate Bill 35's (SB 35) new laws that streamline the approval of much-needed housing projects. Under SB 35, qualifying housing projects are eligible for ministerial review, which can reduce entitlement processing times by months if not years. In Ruegg & Ellsworth v. City of Berkeley (Cal. Ct. App., April 20, 2021, No ...
As COVID-19 vaccinations roll out in the Lao PDR we take this opportunity to answer some of the key questions that are being raised by employers and employees. In our publication and at our upcoming live event, our labor experts outline the rights and obligations of employers and employees when it comes to vaccination in the Lao PDR. Get your answers by downloading the publication and by attending our 20-minute webinar ...
The COVID-19 Pandemic has wreaked havoc on the mortgage servicing industry, putting significant strain on both mortgage servicers and their borrowers ...
The Private Investment Law (Law 10/18 of 26 June) was amended by Law 10/21 of 22 April. The new law marks the return of the contractual system to the area of private investment. As a result, the current private investment systems are the following: i) Prior declaration system ii) Special system iii) Contractual system The contractual system is applicable to projects in any sector ...
In our second quarterly case law update for 2021, we take a look at some of the key cases published since the start of the year and consider the lessons we can learn from them. Disability discrimination In Elliot v Dorset County Council, the Employment Appeal Tribunal (EAT) has recently allowed an appeal against an Employment Tribunal’s finding that a claimant was not disabled ...
