Firm: All
Practice Industry: Healthcare & Pharmaceuticals, Life Sciences
Region: All
Country/ State: All
Tag: All

The U.S. Environmental Protection Agency has announced its temporary policy regarding environmental enforcement activities during the COVID-19 pandemic. The policy is retroactive to March 13, 2020, and will apply for the foreseeable future, until seven days after EPA gives notice that the policy will terminate.     The policy applies to actions for which EPA has federal enforcement authority ...

Veirano Advogados | August 2021

The manufacturer of the official facemask for the Brazilian Football Confederation filed a court action against an e-commerce company, accusing it of offering similar items allegedly manufactured by third parties. The manufacturer of the official facemask for the men’s and women’s teams of the Brazilian Football Confederation (CBF) filed a court action against an e-commerce company, accusing it of offering similar items allegedly manufactured by third parties ...

PLMJ | April 2021

The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...

As corporate policyholders continue to submit claims to their insurers for business interruption and related losses sustained from the COVID-19 pandemic, insurers appear to be denying such claims routinely where the policies at issue contain exclusionary language specific to viruses — whether in stand-alone virus exclusions or other types of exclusions ...

Haynes and Boone, LLP | October 2002

Introduction Although companies may understand the importance of protecting their original ideas, many of them do not know how to do so most effectively. Without an effective intellectual property management system, such companies may be squandering business opportunities and allowing competitors to misappropriate their intangible assets. An intellectual property (IP) audit is a necessary first step for all companies interested in evaluating and maximizing their IP assets ...

Dinsmore & Shohl LLP | December 2020

While most Americans are likely aware that President Donald Trump signed a pandemic relief and government spending bill into law on Dec. 27, 2020 (the “Omnibus Bill”),[i] it is important for those who have intellectual property assets to understand that tucked away into this nearly 5,600-page legislation are laws impacting copyrights, trademarks, and patents ...

Dykema | January 2021

CONGRESS PASSES TRADEMARK MODERNIZATION ACT LEGISLATION In December 2020, the U.S. Congress took action that will have a significant effect on brand holders. At the end of the year, Congress passed the Trademark Modernization Act (“TMA”) that, inter alia, provides additional tools to the USPTO to respond to the rise in improper behavior in trademark filings including filing fraudulent claims of use ...

Dinsmore & Shohl LLP | February 2021

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 ...

Dinsmore & Shohl LLP | January 2021

Effective Jan. 26, 2021, all air passengers traveling to the United States will be required to get a viral test for current infection within the three days before their flight to the U.S. is scheduled to depart, and provide written documentation of their laboratory test results (paper or electronic copy) to the airline ...

Dinsmore & Shohl LLP | July 2021

Health care practitioners are seemingly subject to a constantly growing laundry list of regulatory requirements. However, the Ohio General Assembly has reduced the administrative burden on certain professionals seeking licensure in multiple states through the enactment of interstate license compact legislation ...

The Occupational Safety and Health Administration (OSHA) is making a concerted effort to investigate coronavirus-related cases in which employers allegedly inadequately protected their workers from the pandemic, according to USA Today.[1] A total of 192 COVID-related inspections were launched between Feb. 19 and April 23. The health care industry, including hospitals, skilled nursing facilities, and assisted living facilities, appears to be the focus of the OSHA investigations ...

Brigard Urrutia | March 2020

INVIMA adopts measures aimed at efficiently facing the current health situation related to COVID-19, optimizing the processes that allow the commercialization of products necessary for the prevention of the virus and the evaluation of protocols to prevent it. 1. Declaration of products as Vital Unavailable. Due to the shortage of some supplies in general, the authority has declared that masks, antibacterial gel and disinfecting solutions as Vital Products Not Available ...

Brigard Urrutia | March 2020

Due to the preventive isolation order issued through Decree 457 of March 22nd, 2020 and the powers granted to INVIMA in the sense of guaranteeing the prevention, diagnosis and treatment of Covid-19, within the current state of Economic, Social and Ecological energency ...

Brigard Urrutia | April 2020

New products related to the health emergency by COVID-19 are declared as Non-Available Vitals. Since the issuance of Minute Num. 3 dated March 24, 2020, the Colombian Sanitary Authority, INVIMA, has declared certain products, subdivided in 16 categories, as NON-AVAILABLE VITALS, which as such, can be commercialized without a sanitary registration ...

Brigard Urrutia | March 2020

INVIMA’s specialized board for Medical Devices and other technologies issued a list of declared as Non-Available Vital Products to attend the emergency arising from COVID-19, which means that the import and / or local distribution of said products will be allowed in Colombia without having a Marketing Authorization ...

Brigard Urrutia | April 2020

Decree Number 557 intends to take economical and tax related measures to relieve economic burden to some companies and charity and social solidarity organizations in the context of the economic emergency caused by COVID-19. Specifically, micro and small business as well as associations and solidarity non-profit organizations, will have special discounts applicable to the payment of administrative fees before the sanitary authority, INVIMA ...

Brigard Urrutia | April 2020

INVIMA will prioritize the procedures for pharmaceutical products identified as essential for the treatment of symptoms and complications of COVID-19 ...

Brigard Urrutia | April 2020

Through Resolution 2020012926 of April 3, 2020, INVIMA formalizes the measures adopted in connection with the person to person attention and proceedings that will be carried out before the entity during the health emergency, as well as the suspension of terms for some of INVIMA´s actions ...

Under the patent statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act, or method, and primarily includes industrial or technical processes. The term “machine” used in the statute is self-explanatory ...

Dykema | November 2004

In late October, the IRS released a revised version of its 1023 Form. The new Form requires extensive new disclosures by organizations that seek recognition of tax-exempt status as charities under Section 501(c)(3) of the Internal Revenue Code. Many of the questions added to the exemption application are likely to be included in revised Form 990 information returns scheduled to be released later this year ...

Hanson Bridgett LLP | December 2018

Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...

Hanson Bridgett LLP | January 2018

Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year using IRS Form 1095-C. The IRS uses the forms to assess whether an employer "shared responsibility" penalty applies. Employers also must provide copies of the forms to their full-time employees ...

On March 26, 2021, the Internal Revenue Service (“IRS”) published Announcement 2021-7, which notifies taxpayers that certain amounts paid for personal protective equipment (such as masks, hand sanitizer, and sanitizing wipes) for the primary purpose of preventing the spread of COVID-19 (“COVID-19 PPE”) may be an eligible expense that can be reimbursed from certain health care account based plans ...

Hanson Bridgett LLP | May 2020

Key Points Cafeteria plans may permit mid-year election changes prospectively, including health and dependent care FSA contributions, to address effects of COVID-19 pandemic. Grace period for health and dependent care FSAs may be extended through 2020, even for plans that allow carryovers. Employers must notify eligible employees of temporary plan changes, and adopt plan amendments by the end of 2021 ...

dots