JURIST

MARCH 3, 2022

The United Nations Environment Assembly Wednesday approved a resolution to establish the first-ever global agreement on plastic pollution, along with a series of draft resolutions concerning biodiversity, health, the green economy, and circularity. ” An estimated 11 million metric tons of plastic enter the ocean each year.

Manufacturing 197

Manufacturing Drafting Legal Legal 197

FDA Law Blog

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).

Healthcare 75

Healthcare Manufacturing Drafting Construction 75

ClimateChange-ClimateLaw

OCTOBER 16, 2023

history during which entities that do not have federal tax liability – including local and state governments and agencies, nonprofit organizations, tribes and municipal utilities – can reap the benefit of these incentives. The Inflation Reduction Act (IRA) is chock-full of tax incentives for climate and clean energy projects.

Government 135

Government Manufacturing Finance Drafting 135

FDA Law Blog

SEPTEMBER 6, 2022

Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance). This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Not all that much.

Drafting 52

Drafting Manufacturing Government 52

Customs & International Trade Law

FEBRUARY 9, 2024

Department of Commerce (Commerce) has determined are sold in the United States at less than fair value and subsidized by the Government of China. Justice Department announces charges and arrest in two separate illicit technology transfer schemes to benefit governments of China and Iran. technology to Iran.

Technology 52

Technology Drafting Manufacturing Government 52

ClimateChange-ClimateLaw

MARCH 29, 2024

Current estimates are that the law will impact over 10,000 companies, which will have to draft a report every two years, beginning January 1, 2026, and publish it on their own website. This bill captures more companies, with a lower revenue threshold of over $500 million instead of $1 billion. See, e.g. , Rice v.

Laws 70

Laws Government Drafting Manufacturing 70

Customs & International Trade Law

APRIL 29, 2022

Food and Drug Administration ( FDA ) announced the availability of a draft guidance for industry entitled The Accredited Third-Party Certification Program: Questions and Answers: Guidance for Industry. CBP officers determined that the rings had a total Manufacturers Suggested Retail Price (MSRP) value of approximately $15,000.

Laws 87

Laws Drafting Calendaring Administrative Law 87

FDA Law Blog

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug. In other words, FDA cannot regulate a device as a drug on a whim.

Court 40

Court Manufacturing Statute Technology 40

Broadcast Law Blog

MAY 14, 2023

This is part of the increasing Congressional concern over the plans of certain manufacturers to remove AM radios from new cars. The annual fees are paid by all entities that the FCC regulates to reimburse the government for the cost of FCC operations.

Construction 97

Construction Manufacturing Drafting Government 97

Patently O

JUNE 6, 2021

and ISE (Trimble’s wholly-owned subsidiary) (Trimble | Plaintiff) offer geofencing and logging technologies along with manufacturing and selling positioning devices. PerDiemCo is the assignee of eleven patents [1] at issue, all related to geofencing and electronic logging technology (commonly used in the trucking industry). Trimble, Inc.,

Law School 130

Law School Laws Litigation Litigating 130

The Fashion Law

OCTOBER 6, 2021

After mentioning Environmental, Social, and Governance – or “ESG” – almost 100 times in the nearly 60-page S-1 that it filed with the Securities and Exchange Commission (“SEC”) in August, Allbirds is reigning its sustainability-centric declarations back a bit. The Impact of ESG Disclosures.

Drafting 58

Drafting Manufacturing Government Attorney 58

Customs & International Trade Law

APRIL 22, 2022

The report finds what ACE reduced government processing times by more than 90%! On April 15, 2022, the FDA published a draft guidance for industry on developing drugs to treat celiac disease, “Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet.” million, Italy at $72.54 million, and France at $67.39

Laws 90

Laws Manufacturing Administrative Law Drafting 90

Patently O

MARCH 26, 2024

Water-tight compartments for adjusting a vessel’s depth while maintaining an even keel had long been employed in dry docks and light-draft monitors, while the use of revolving screws to stir up and remove sediment had been practiced by French steamers and the dredging vessel apparently named after Enoch Train. 63, 67 (2020).

Manufacturing 59

Manufacturing Court Technology Laws 59

ClimateChange-ClimateLaw

NOVEMBER 12, 2016

The hope is that they can reach consensus on draft text, which will be presented for approval at the plenary sessions next week. In addition to a forum for negotiations, COP22 also provides an opportunity for the exchange of ideas on climate change mitigation and adaptation strategies, between governments, companies, and others.

Technology 52

Technology Government Manufacturing Finance 52

Strictly Business

FEBRUARY 12, 2024

The purchase agreement is typically drafted by the buyer’s counsel after the letter of intent has been signed and the buyer has done enough due diligence to feel confident that it wants to pursue the transaction. Miscellaneous provisions – this can include things like governing law and venue (i.e.,

Diligence 83

Diligence Real Estate Contract Business Services 83

Strictly Business

JANUARY 11, 2024

For example, the following are commonly examined in depth for the buyer in an acquisition: Corporate governance and structure, including incorporation or formation documents and related shareholder or member agreements, ownership of the entity, and minutes of meetings and other resolutions. This article is for general information only.

Diligence 83

Diligence Contract Document Review Real Estate 83

FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. The Guidance highlights that the firm should identify specific points of contact for internal communications, communications with FDA, and communications to direct accounts or the public ahead of time and maintain draft templates for prompt communication.

Manufacturing 40

Manufacturing Drafting Legal Legal 40

Patently O

SEPTEMBER 13, 2021

Most significantly, HTC was the developer and manufacturer of Google’s Nexus One Android phone , which was released in 2010. These standards are covered by tens of thousands of patents around the world (standards-essential patents or SEPs), a respectable number of which are held by Swedish equipment manufacturer Ericsson.

Contract 56

Contract Manufacturing Contract Law Court 56

Conflict of Laws

SEPTEMBER 23, 2021

The first approach, advanced primarily by the courts, characterises the trust as an equitable obligation governed by the lex fori. The second approach, primarily endorsed by commentators, characterises the trust as an issue of immovable property governed by the lex situs.

Laws 52

Laws Family Law Legal Legal 52

Conflict of Laws

OCTOBER 23, 2023

Carnival relied on the orthodox approach, prioritising choice of law rules in controlling when and to what extent forum statutes will apply, and more aligned with comity norms and party autonomy the selection of the governing law of private agreements. where was the defective product manufactured, or where was the injury sustained).

Laws 57

Laws Contract Statute Construction 57

Conflict of Laws

JANUARY 27, 2021

With the government draft of 25 September 2020, a comprehensive reform of guardianship and care law is approaching which will fundamentally modernize these areas. Therefore, it has to be concluded that the present article reflects the current state of law as established by the Trade and Cooperation Agreement (Rolf Wagner).

Construction 52

Construction Laws Court Government 52

Patently O

JANUARY 12, 2023

In recent years, certain foreign governments have shown themselves willing to hold-up international disease research and response efforts in order to gain concessions and advantages for themselves under the banner of “ access and benefit sharing ” (ABS).

Technology 90

Technology Litigation Litigating Manufacturing 90

SCOTUSBlog

DECEMBER 4, 2023

The manufacturer of the drug, Purdue Pharma, promoted the drug as less susceptible to abuse, but OxyContin proved instead to be highly addictive. Representing the federal government, Deputy Solicitor General Curtis Gannon told the justices that the releases for the Sacklers go beyond what Section 1123(b)(6) allows.

Court 136

Court Government Litigation Litigating 136

FDA Law Blog

NOVEMBER 16, 2021

1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)

Manufacturing 52

Manufacturing Government Entertainment Drafting 52

SCOTUSBlog

FEBRUARY 28, 2022

The Controlled Substances Act makes it unlawful for “any person knowingly or intentionally … to manufacture, distribute, or dispense” a controlled substance, “[e]xcept as authorized by this subchapter.” Their appeals center on challenges to their jury instructions, which they argue did not properly emphasize this good-faith component.

Mens Rea 84

Mens Rea Court Government Manufacturing 84

FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

Drafting 52

Drafting Statute Data Management Manufacturing 52

Conflict of Laws

SEPTEMBER 21, 2023

– being primarily responsible for manufacturing and selling Huawei’s smart terminal products – was domiciled there. In practice, courts may apply either the law of the forum or the law governing the main contract to this matter, leading to uncertainty.

Procedural Law 57

Procedural Law Laws Litigation Litigating 57

FDA Law Blog

AUGUST 3, 2022

If anything, the announcement was remarkably inconspicuous: a seemingly throwaway sentence in a draft compliance policy guide for research use only and investigational use only products. Opponents view the same facts in precisely the opposite way: it is critical that government regulation not stifle this innovation.

Manufacturing 98

Manufacturing Drafting Government Legal 98

The Crime Report

NOVEMBER 28, 2022

With more than 200 Americans still dying of drug overdoses each day, states are beginning the high-stakes task of deciding how to spend billions of dollars in settlement funds from opioid manufacturers and distributors. The strife in Ohio highlights the tensions emerging nationwide as settlement funds start flowing.

Education 98

Education Manufacturing Attorney Government 98

The Process Street

FEBRUARY 8, 2021

The principle of lean Six Sigma is simple: it combines the waste reduction and workflow efficiency of lean manufacturing with the defect-elimination process of Six Sigma. This impacts how quickly writers can make those revisions, have final drafts approved, and publish their content.

Manufacturing 103

Manufacturing Drafting Construction Technology 103

FDA Law Blog

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog. FDA will consider if technologies and device features “address unmet needs in these populations” when evaluating criterion one.

Healthcare 53

Healthcare Drafting Technology Manufacturing 53

Conflict of Laws

MAY 20, 2024

It mandates that companies, along with their associated partners in the supply chain, manufacturing, and distribution, must take steps to avoid, halt, or reduce any negative effects they may have on human rights and the environment. As was mentioned above, the CSDDD is mostly silent on PIL.

Diligence 77

Diligence Litigation Litigating Laws 77

The Process Street

APRIL 22, 2021

What is the roadmap to achieve the goals – marketing, operations, research and development, manufacturing, and financial plans? It includes facilities, supply chain management, inventory, manufacturing, shipment, logistics, staff management – everything under the sun that covers capital and expense (CapEx) requirements.

Small Business 107

Small Business Drafting Manufacturing Legal 107

ClimateChange-ClimateLaw

DECEMBER 12, 2023

Germany that the federal government must adopt an immediate action program (‘Sofortprogramm’) under the Federal Climate Change Act (CCA). Germany of the Federal Constitutional Court, the focus of the decision is not on fundamental rights, but on administrative questions of climate governance and enforcement.

Litigation 142

Litigation Litigating Government Court 142

Foley Hoag LLP

JANUARY 28, 2022

If passed and signed into law, the Act would create significant reporting requirements related to environmental sustainability, social development (in particular worker rights), and ethical business (ESG) standards for retailers and manufacturers. Companies would have twelve months to map out a minimum of 50% of their supply chain by volume.

Diligence 40

Diligence Manufacturing Attorney Drafting 40

The Process Street

JUNE 30, 2022

You can run the calculations if you’re using your SOPs to govern a manufacturing process, which can be accounted for easily by numbers. Under those circumstances, send the results of any testing you have undertaken and the draft SOPs. Consider whether things can go wrong once you have your process on paper.

Construction 105

Construction Manufacturing Small Business Drafting 105

JURIST

JANUARY 28, 2023

Notably, soldiers recruited through the recently introduced and hotly debated “Agniveer” recruitment scheme of the Central Government also took part in the march on Kartavya Path. A total of 24 tableaux (“floats”), including 17 from India’s states and 6 from various government ministries and departments, graced the boulevard.

Government 104

Government Manufacturing Drafting Laws 104