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that the previous policy announced by the Department of Health and Human Services (HHS) on Jan. 15, 2021, was being rescinded because the new policy would have required the FDA to publish redundant information about new applications of NDAs and ANDAs ...
More than three years after initial publication, the State Medical Board of Ohio's proposed revisions to its light-based device (laser) rules are now advancing toward possible enactment, as the Medical Board has announced amendments to the proposal and scheduled public rules hearing for May 17, 2021 ...
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 ...
On April 26, 2021, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced on its OCR Security List Digest that OCR had been made aware of misleading postcards being sent to health care organizations. The postcards inform recipients that they must participate in a “Required Security Risk Assessment.,” It directs them to send their risk assessment to www.hsaudit.org, a non-governmental website marketing consulting service ...
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 ...
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 impact of the pandemic can be seen across all sectors of society but those who are disabled have been particularly affected, not least because employees with an underlying disability are likely to have been identified as clinically extremely vulnerable and told to shield for considerable parts of the last year. Being away from the workplace and separated from colleagues has left many feeling insecure ...
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 ...
In this second instalment of our series 'Navigating the new regulatory landscape for Company Service Providers', we take a closer look at the application process for CSPs seeking regulatory authorisation, the appointment of key office holders and applicable exemptions to the new regime. Part 1 of this series can be accessed here ...
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 ...
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 ...
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 ...
Following the entry into force of the Company Service Providers (Amendment) Act 2020 (the "Amendments") on 16 March, 2021 a number of significant amendments have been introduced to the local regulatory framework governing the provision of company services. The most notable amendments consist of the removal of previous exemptions available to warranted professionals and the end of the de minimis rule ...
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 ...
As part of its 2022 Inpatient Prospective Payment System (IPPS) Proposed Rule for Acute Care Hospitals, the Centers for Medicare and Medicaid (CMS) is proposing an increase for Medicare fee-for-service payment rates to acute care hospitals by 2.8 percent, or $3.4 billion in Fiscal Year (FY) 2022.[[1]] Hospitals hoping to receive the payment increase must successfully participate in the Hospital Inpatient Quality Reporting Program and be meaningful electronic health record users ...
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”) ...
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 ...
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. The EAT held that the Tribunal had failed to adopt the correct approach when determining whether the claimant had a disability according to the statutory definition of disability in section 6 of the Equality Act 2010 ...
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 ...
Did you know? The Measures for the Supervision and Administration of Online Transactions (“Measures”) released by the PRC State Administration for Market Regulation will come into force on 1 May 2021 and will replace the previous rules implemented in 2014. Among other things, the Measures impose more stringent requirements against the common practice of “bundled consent” ...
There have been a number of significant rulings on the topic of holiday pay over recent years and Smith v Pimlico Plumbings Ltd is the newest addition. Before we look at Smith, it is useful to understand how this area of law has developed over time ...
