On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
The use of telehealth skyrocketed during the COVID-19 public health emergency, as many regulatory barriers restricting its use were temporarily removed at the federal and state level and by private payors. Providers and patients adapted to the changes and are now relying on these flexibilities to deliver and receive high quality virtual care. This rapid expansion of the use of telehealth has ignited the need for permanent telehealth reform ...
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 ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
Michigan has joined the majority of jurisdictions in holding that a general liability policy may provide coverage for claims for property damage allegedly caused by the defective work of a subcontractor ...
The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire concurrently with the expiration of the PHE on May 11, 2023 at 11:59 PM ...
Many organizations may be parties to contracts where the counterparty is seeking to cancel its obligations because of COVID-19. This situation is arising in relation to various commercial relationships, including supply agreements, events planning contracts, and numerous other types of agreements ...
The Centers for Disease Control (CDC) reports swimming is the fourth most popular recreational activity in the United States and the most popular recreational activity for children (ages 7 to 17). Statistics further show 36 percent of children and 15 percent of adults go swimming at least six times a year in the United States ...
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 ...
In this article we look at the impact the COVID-19 pandemic has had on the social and health care sector in the build up to the upcoming Public Inquiry, due to commence in Spring 2022. Upsetting scenes arising from the COVID-19 pandemic included photographs of bereaved families with only six people in attendance at family funerals ...
This 28th edition of Unprecedented, our weekly update on COVID-19-related litigation, includes a number of updates on the mounting number of business interruption coverage disputes -- including a claim against a broker whose alleged failure to obtain infectious disease coverage left the insured without coverage for COVID-19-induced losses ...
The offence of spreading coronavirus From what point exactly is the spreading of COVID-19 a criminal offence? Is it only intentional spreading that is punishable or is negligence also a criminal offence? What is at stake? What are the aggravating circumstances and when do the penalties increase? And can these criminal offences also be committed by a legal entity? The Government of the Czech Republic adopted, as a part of emergency measures due to health threat, Regulation No ...
On May 27, 2020, the U.S. Patent and Trademark Office issued a further extension of certain deadlines that were about to expire on May 31. The latest order provides until July 1, 2020 for certain actions delayed due to COVID-19. For small and micro entities only, filings that would have been accepted if filed by June 1, 2020, will now be deemed timely if filed by July 1, 2020 ...
In order to limit the spread of COVID-19 and mitigate its effects, on 12 March 2020, the Government of the Republic of Estonia declared an emergency situation until 1 May 2020 and the Health Board recommends avoiding human contact. In this situation, implementing effective safety measures at the workplace often requires asking additional personal data, including health data from the employees ...
The Prime Minister has approved, and government has published the long-awaited final terms of reference for the COVID-19 Inquiry. The inquiry, chaired by the Rt Hon Baroness Heather Hallett DBE, is two-fold and will: 1. Examine the COVID-19 response and the impact of the pandemic in England, Wales, Scotland and Northern Ireland, and produce a factual narrative. 2. Identify the lessons to be learned from the above, to inform preparations for future pandemics across the UK ...
The coronavirus disease (COVID-19) outbreak continues to put pressure on the public and private sectors alike. As we are entering new phases of the COVID-19 pandemic, we have to switch our focus towards safely and gradually reopening our businesses and economies while continuing to implement prevention measures ...
This briefing takes a deeper dive into the labor and employment aspect of COVID-19 issuances. Some of the guidelines here are covered in our The Return-to-Work-Checklist for Philippine Companies. A. Operating establishments have been directed to comply with public health standards prescribed by the Department of Health (DOH), Department of Trade and Industry (DTI) and the Department of Labor and Employment (DOLE) 1. The DTI issued DTI Memorandum Circular No ...
By resolution adopted on October 7, 2020, the state of emergency has been extended until January 31, 2021 ...
New measures to curb the “second wave” of COVID-19 cases have been introduced by the Dubai Supreme Committee of Crisis and Disaster Management (the Dubai Committee) and the Abu Dhabi Emergency Crisis and Disasters Committee for COVID-19 Pandemic (the Abu Dhabi Committee) ...
Since the publication of our legal update on COVID-19 Legal Challenges for Pharmaceutical Companies on 31 March 2020, new important measures were adopted or announced on both national and EU level ...
Upon the ongoing spread of coronavirus disease (“COVID-19”) pandemic, the Indonesian Government has declared the COVID-19 as a national emergency situation. Following the nation’s COVID-19 emergency, the Indonesian Government have issued sets of regulations and policies in various sectors in order to control and mitigate the adverse impacts of the COVID-19 pandemic ...
It’s been more than a year since the COVID-19 pandemic began, and many companies are attempting to market products intended to help consumers deal with the risks associated with COVID-19. Some of the most common examples of such products include face masks, testing devices, hand sanitizers, and hard-surface disinfectants ...
