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Practice Industry: Healthcare & Pharmaceuticals, Industrial & Manufacturing, Life Sciences
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Wardynski & Partners | October 2013

In the innovativeness of its economy, Poland ranks 4th from last in the European Union, but greater support is planned for highly innovative projects that show promise for implementation and commercialisation in Poland. At a session of the Polish Parliament’s Innovation and New Technology Committee on 19 June 2013, the Ministry of Regional Development presented the guidelines for operational programmes Smart Growth 2014–2020 and IT & Telecommunications 2014–2020 ...

Simonsen Vogt Wiig AS | December 2023

There was considerable anticipation regarding whether the negotiations would be successfully concluded during this meeting. Without an agreement, there was a risk of significant delays in the adoption of the framework. This was undesirable for EU institutions that have invested considerable prestige in leading the regulation of AI globally. Read more about the most contentious issues leading up to the last negotiation meeting in this article ...

Waller | April 2020

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) includes $100 billion for Medicare and Medicaid-enrolled suppliers/providers that provide diagnosis, testing or care for individuals with possible/actual cases of COVID-19 ...

Dinsmore & Shohl LLP | April 2019

The U.S. Food and Drug Administration (FDA) recently announced new steps it is taking to determine a framework for lawful marketing of appropriate cannabis and cannabis-derived products.[i] As expressed in the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), the FDA has the authority to regulate products containing cannabis or cannabis-derived compounds ...

Haynes and Boone, LLP | June 2003

On October 16, 2003, the Health Insurance Portability and Accountability Act (“HIPAA”) requires employer-sponsored group health plans and others to be in compliance with the Transaction and Code Sets (“TCS”) standards for electronic transactions adopted by the Department of Health and Human Services (“HHS”). The federal government has been warned of potential disruption in the claim submission and payment cycles because the health care industry remains substantially non-compliant ...

Dinsmore & Shohl LLP | July 2022

Within hours of the U.S. Supreme Court’s decision overturning Roe v. Wade, Ohio’s Heartbeat Bill, originally passed in 2019, became effective when the U.S. District Court, Southern District of Ohio, lifted its long pending injunction against the Ohio law ...

Waller | October 2017

President Donald Trump announced that the federal government will halt payments known as cost share reduction (CSR) payments. The CSR payments amounted to approximately $7 billion this year, and served as a subsidy to enable lower-income Americans to afford health insurance coverage ...

Lavery Lawyers | October 2023

A patent landscape provides a bird?s-eye view of the patenting activity related to a specific technology. It can be an invaluable tool for your organization as the analysis of patent data reveals business, scientific and technological trends. Indeed, many industries increasingly rely on patent landscapes to provides a basis for understanding innovation activity in their field ...

Kudun and Partners | February 2020

Thailand is at a powerful crossroads in its economic development. After several decades of consistent growth, it is now preparing to finally break through and become a high-income nation. To do this, it is focusing on smart industry. A high-income Thailand is one driven by technological progress, so the government has begun pouring money into robotics and automation ...

Buchalter | December 2023

By: Daniel Silva, Sanjay Bhandari, and Manisha Malhotra The Paycheck Protection Program (“PPP”) emerged as a lifeline for small businesses grappling with the unprecedented challenges of the COVID-19 pandemic. Lenders navigated a landscape of regulations that Congress quickly drafted in response to the pandemic. These regulations and obligations evolved, subtly yet materially, from the first and second rounds of PPP “draws ...

Han Kun Law Offices | June 2021

On June 10, 2021, the Standing Committee of the National People’s Congress adopted the Anti-Foreign Sanctions Law (the “Anti-Sanctions Law”) ...

ALTIUS/Tiberghien | November 2020

The legal status of CBD, a naturally occurring compound found in the cannabis plant, is murky. Certain Member States are more restrictive about it than others. The Court of Justice of the EU has very recently provided clarification in the context of a preliminary ruling (case C-663/18 of 19 November 2020). This case revolves around CBD’s ban in France, after it had been imported from the Czech Republic where it was lawfully produced ...

Hanson Bridgett LLP | April 2021

Food producers can breathe a sigh of relief, at least temporarily, thanks to efforts by the California Chamber of Commerce resulting in a preliminary injunction barring the State of California and all private plaintiffs from filing any new Proposition 65 lawsuits targeting acrylamide in food and beverage products. On March 31, 2021, Chief United States District Judge for the Eastern District of California, Kimberly J ...

Shoosmiths LLP | April 2022

On 6 April 2022, Shoosmiths hosted the second in a series of webinars about the UK COVID-19 Public Inquiry. The webinar focussed on the current status of the inquiry and gave practical tips for potentially interested parties. Hosted by Hayley Saunders (Partner), the webinar included talks by Charles Arrand (Partner), Alex Friston (Associate) and Hannah Frost (Associate) ...

Plaintiffs’ counsel in pharmaceutical product liability cases continue to pursue depositions of company sales representatives and seek to elicit testimony supporting their common theme that pharmaceutical companies disregard the health and safety of their consumers in the dogged, single-minded pursuit of sales and profits ...

Dinsmore & Shohl LLP | March 2024

At any hour, your company is vulnerable to cybercriminals aiming to cripple your operations. The repercussions are vast, from productivity loss to compromising sensitive information, which erodes trust with customers and employees alike. The financial toll and reputational harm can be severe and lasting. Whether facing a widespread assault or a precise strike, these attacks are escalating in frequency, sophistication and financial impact ...

Hunton Andrews Kurth LLP | December 2012

The U.S. District Court for the Eastern District of Virginia recently overturned the United States Patent & Trademark Office ("USPTO") interpretation of the patent term adjustment ("PTA") statute in Exelixis, Inc. v. Kappos. Similar to Wyeth v. Kappos, where a previous USPTO interpretation of the PTA statute was overturned, the Exelixis decision promises to add months and even years to the patent term of many patents ...

Dinsmore & Shohl LLP | September 2021

President Joe Biden announced Thursday, Sept. 9, that in the coming weeks, companies with 100 or more employees will be required to ensure their employees are vaccinated against COVID-19 or test negative for COVID-19 at least once a week.[1] Additionally, employers must provide employees time off to get vaccinated and to recover from any side effects. Press Secretary Jen Psaki previewed the forthcoming requirements in her briefing to the press on Thursday ...

Haynes and Boone, LLP | August 2015

The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...

PLMJ | July 2022

Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...

Dinsmore & Shohl LLP | January 2020

The Centers for Medicare & Medicaid Services (CMS) recently released a final rule, which will require hospitals to publicly disclose pricing information, effective January 1, 2021 ...

Waller | October 2021

On October 14, 2021, the Massachusetts Attorney General’s Office announced a $25 million healthcare fraud settlement against a private equity firm and former executives of the firm’s portfolio company. The settlement is significant because it is the largest healthcare fraud settlement in the country to date against a private equity firm based on the firm’s oversight of its healthcare portfolio company ...

Hanson Bridgett LLP | September 2020

Key Points HHS Provider Relief Fund payments are being extended to private pay assisted living facilities under Phase II. Relief will be equal to 2 percent of annual gross revenue from resident care. Interested providers must act swiftly: the deadline to submit basic information to HHS is Sept. 13 Provider relief funds need not be repaid if recipients comply with the program criteria. HHS Announcement: On Sept.1, the U.S ...

Lavery Lawyers | September 2014

In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...

Shoosmiths LLP | October 2023

Module 5 will assess the robustness and effectiveness of procurement processes, the adequacy of items obtained (including their specification, quality, and volume) and the effectiveness of their distribution. It will also consider the UK-wide procurement of lateral flow and PCR tests. The provisional scope for this module lists three key areas of investigation ...

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