Firm: All
Practice Industry: Energy & Natural Resources, Healthcare & Pharmaceuticals
Region: All
Country/ State: All
Tag: All

Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...

Carey | February 2023

On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 401/23 the technical guide for the sanitary registration of allergens with the purpose of establishing the guidelines and requirements for the sanitary registration of these products (the "Guide") ...

Carey | February 2023

On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 405/23 the technical guide on homeopathic products with the purpose of providing the guidelines and requirements for the request of the sanitary registration of these pharmaceutical products in order to provide complete and updated information that supports the quality, safety and efficacy of these products (the "Guide") ...

Dinsmore & Shohl LLP | February 2023

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 ...

Dinsmore & Shohl LLP | February 2023

Over the past few weeks, the investigation of sexual misconduct cases by the State Medical Board of Ohio (“Board”) has continued to make headlines across Ohio. Due to an increased public outcry as a result of the recent media attention, as well as the previous revelations of the Board’s handling of the Dr ...

Kudun and Partners | February 2023

On the occasion of Children’s Day on January 12, 2023, Kudun and Partners launched an internal donation drive on January 12 to rally firm members to support children’s centers in Bangkok and Hat Yai. The donation drive was initiated as part of the firm’s continuous aspiration to contribute back the society ...

Schwabe, Williamson & Wyatt | February 2023

The window for low-income service providers to take advantage of funds available through the Oregon Solar+ Storage Rebate Program is closing. Each year, 25 percent of the program’s budget is allocated to low-income and moderate-income homeowners and service providers. This year, the non-income-restricted funds have already been disbursed, and only low-income and moderate-income restricted funds remain ...

Carey | February 2023

On February 14 of this year, the Public Health Institute ("ISP") approved -by means of Ex. Res. No. 369/2023- a new guideline regarding the performance of post-authorization safety studies of pharmaceutical products (the "Guideline") ...

Shoosmiths LLP | February 2023

Hydrogen is often touted as the future of green industry, heating and fuels. It certainly has the capability to be just that, but there are many hurdles along the way to be overcome.   In truth, while there are many methods to produce hydrogen, only four could potentially reach carbon zero ...

Quarles & Brady LLP | February 2023

On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research ...

Texas is increasingly a purple political state. The motto of the state's capital city implores its citizens to keep it weird.[1] Recent polling shows that Texans overwhelmingly support medical cannabis.[2] Every one of Texas' neighboring states has a real medical cannabis program ...

Dinsmore & Shohl LLP | February 2023

On February 1, the Federal Trade Commission (“FTC”) announced enforcement action for the first time under its Health Breach Notification Rule[1]. The complaint against telehealth and prescription drug discount provider GoodRx Holdings Inc. (“GoodRx”), alleges its failure to notify consumers and others of its unauthorized disclosures of consumers’ personal health information to Facebook, Google and other companies ...

Dinsmore & Shohl LLP | February 2023

The Department of Justice (“DOJ”) withdrew three longstanding healthcare antitrust enforcement policy statements on the afternoon of Friday, February 3, 2023. The move follows a series of White House antitrust initiatives ...

Dinsmore & Shohl LLP | February 2023

At the end of 2022, the Centers for Medicare and Medicaid (“CMS”) issued a proposed rule that would amend the standard imposed on Medicare providers to report and return overpayments. If finalized, the proposed rule would replace the 60-day overpayment rule’s current “reasonable diligence” standard with the False Claims Act “knowingly” standard ...

Dinsmore & Shohl LLP | February 2023

As reported by various news outlets, the State Medical Board of Ohio (“Board”) has, and will continue, to ramp up investigations and enforcement actions related to alleged violations of ethical and professional guidelines. In particular, professional boundaries and sexual misconduct issues will be a primary focus for the Board, as it has been since the revelations of the Dr. Richard Strauss case became public ...

Shoosmiths LLP | February 2023

This week marks Children's Mental Health Week (6-12 February 2023). The focus on mental health has been increasing in recent years, with one in six children aged between five and 16 likely to have experienced mental health challenges. As a result, there are a growing number of workdays lost by parents, guardians, carers, and those with childcare responsibilities, to support and manage such challenges ...

Dinsmore & Shohl LLP | February 2023

On January 1, 2023, the Ohio Board of Nursing joined the multi-state Nurse Licensure Compact (“NLC”), allowing nurses who hold an Ohio nursing license to apply for a multi-state license.    Ohio has joined at least 37 other states that participate in the multi-state license ...

Dinsmore & Shohl LLP | January 2023

As previously discussed in our January 5, 2023 legal alert, the Pennsylvania Department of Human Services (“Pennsylvania DHS”) issued a Medical Assistance Bulletin (the “Bulletin”) in late December, 2022 that had the potential to put 340B savings at risk in Pennsylvania ...

On April 27, 2022,Republic Act No. 11712, or thePublic Health Emergency Benefits and Allowances for Health Care Workers Act(“RA 11712”), was signed into law in recognition of the critical role of health care workers in providing quality health care and ensuring disease prevention in the general population, especially during the pandemic. It seeks to promote the welfare of health care workers through the grant of mandatory benefits and allowances with utmost efficiency ...

With the decreasing number of positive COVID-19 cases, more employees are now returning to on-site work and new COVID-19 testing protocols are in place. The Inter-Agency Task Force for the Management of Emerging Infectious Diseases (“IATF”) provided guidelines for COVID-19 testing requirements for unvaccinated and partially vaccinated employees through its Resolutions No. 148-B and 149. Also, the National COVID-19 Immunization Program opened to the general public nationwide ...

Dinsmore & Shohl LLP | January 2023

On January 5, 2023, the Federal Trade Commission (“FTC”) issued a Proposed Rule that would prohibit employers from enforcing non-compete agreements against former employees, contractors, and other workers. Dinsmore & Shohl’s Labor and Employment Group’s legal alert on January 5, provides general information about the changes envisaged in the Proposed Rule ...

Shoosmiths LLP | January 2023

July 2022 saw the formal commencement of the UK Covid-19 Inquiry. Opened by Inquiry Chair Baroness Heather Hallett, we later witnessed preliminary hearings for Modules 1 and 2, held in October and November. As a reminder, Modules 1 and 2 cover the overarching topics of the UK’s pandemic preparedness and resilience, and core political and administrative decision-making throughout the UK (incorporating sub-modules for Scotland, Wales and Northern Ireland), respectively ...

Carey | January 2023

On January 17, 2023, the Institute of Public Health ("ISP") –by means of Res. Ex. No. 106– approved the Good Manufacturing Practice Guideline for Medical Devices and In Vitro Diagnosis Medical Devices (the "Guideline") ...

Shoosmiths LLP | January 2023

To help further the objectives of the Women’s Health Strategy for England (published by the Department of Health and Social Care in July 2022) £1.97m has been awarded to help women in the workplace who are experiencing reproductive health issues. The grant will be shared between 16 charities which include, amongst others, Fertility Network UK, Sands, Tommy’s and Mind ...

Shoosmiths LLP | January 2023

We have recently seen reports about the unbelievable amount of pressure on the NHS, including inaccessibility to GPs; a high degree of emergency admissions; and bed-blocking within hospitals where vulnerable patients cannot be discharged safely. These factors have exacerbated the pressure on our healthcare system to almost unprecedented levels. Medical technologies or MedTech could be the way forward to ease some of the pressure ...

dots